MAUDE Adverse Event Report: CORDIS DE MEXICO OUTBACK RE-ENTRY CATHETER; CTO CATHETER SYSTEMS (DQY)

Catalog Number OTB42120

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2013

Event Type  malfunction  

Event Description

During use of an outback re-entry catheter, it was reported that the device could not advance further into the target vessel and that the outback kept getting caught up on the wire during insertion.After the device was removed and the non-cordis wire was removed, the wire would no longer go through the outback catheter guidewire lumen.They decided to use a second outback.During advancement, it could not reenter the true lumen because of calcification of the arteries.The outback was removed and the patient was consulted for surgery.There was no known injury to the patient.The intended procedure was a right superficial femoral artery (sfa) diagnostic with possible intervention.The target lesion was located in the right superficial femoral artery with an occlusion of the mid sfa with collateral reconstitution.The lesion was heavily calcified and tortuosity is unknown.During the procedure, the non-cordis guidewire, which was already in place at the vasculature of the patient, was back loaded into the distal end port of the nosecone of an outback re-entry cto catheter.After the device was inserted, they noticed difficulty with the device.The outback advanced over the bifurcation but then had difficulty advancing further into the sfa and it kept getting caught up on the wire.They removed the outback and removed the wire.They tried to reinsert the wire into the guidewire lumen while outside the body, but it would not re-enter.It wa reported that there was no foreign material observed in the device.Another outback catheter was opened and inserted into the patient.The deployment of the needle was checked prior to insertion.The new outback was inserted over the same wire and it advanced past the lesion.However, the physician could not reenter the true lumen because of the amount of calcification in the artery.

Manufacturer Narrative

There was no difficulty deploying the needle and it was not too dull.Therefore, it was removed and the patient was consulted for surgery.There was no known injury to the patient.During analysis of the device, there was an obstruction at 73.0cm from distal tip end noted and resistance was felt due to obstruction of the gw lumen.A cross sectional analysis was performed to identify the cause of obstruction in the gw lumen; and found 4.0cm of unknown gw causing obstruction in the gw lumen.It is currently unknown if the guidewire was in the device prior to use or if a guidewire was fractured and separated in the device during use.Please note that the gender of the patient is unknown.Concomitant devices: bentson wire 035x150 (sgw-035-04) or asahi grand slam 014x300 (14940-01).The device has been returned for analysis.A device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.Product analysis: one non sterile catheter outback was received coiled inside a plastic bag.The cannula was received deployed.There were blood residues observed in the returned device.No kinks or bents observed in the returned device.No other anomalies were observed in the returned device.The device was flushed however the water not came out the tip due to obstruction in the gw lumen.Insertion/withdrawal test was performed with lab sample 0.014"gw and the gw was inserted in the cannula guide wire port , however the gw could not be inserted through all the catheter lumen due to an obstruction at 73.0cm from distal tip end , resistance was felt due to obstruction of the gw lumen.The catheter shaft/nosecone spins smoothly as the rhv was rotated.The applicable cannula deployment test was performed and the cannula was fully deployed and retracted without difficulty.Cross sectional analysis was performed to identify the cause of obstruction in the gw lumen; the catheter was cut at 73.0cm from distal tip and was found 4.0cm of unknown gw causing obstruction in the gw lumen.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The failure cto catheter system tracking difficulty reported by the customer was not confirmed since no damages were found during analysis.The exact cause of the failure reported by the customer could not be determined.The failure cannula wire port/guide wire lumen resistance/friction reported by the customer was confirmed since the gw could not be inserted through all the catheter lumen due to an obstruction at 73.0cm from distal tip end, resistance was felt due to obstruction of the gw lumen.The failure cannula wire port/guide wire lumen obstructed reported by the customer was confirmed since obstruction was detected at 73.0cm from distal end.The obstruction was caused by 4.0cm of unknown guide wire.The cause of the failure could not be conclusively determined.Neither the dhr review nor the product analysis suggests that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Manufacturer Narrative

Additional information has been received: the sales rep was able to speak to the physician, and the broken wire that was found within the outback was a wire that the physician had inserted.He was unaware that a few centimeters of the wire had broken off when he removed it.Additional information is pending and will be submitted 30-days upon receipt.

Manufacturer Narrative

Complaint conclusion: during use of an outback re-entry catheter, it was reported that the device could not advance further into the target vessel and that the outback kept getting caught up on the wire during insertion.After the device was removed and the non-cordis wire was removed, the wire would no longer go through the outback catheter guidewire lumen.They decided to use a second outback.During advancement, it could not re-enter the true lumen because of calcification of the arteries.The outback was removed and the patient was consulted for surgery.There was no known injury to the patient.The intended procedure was a right superficial femoral artery (sfa) diagnostic with possible intervention.The target lesion was located in the right superficial femoral artery with an occlusion of the mid sfa with collateral reconstitution.The lesion was heavily calcified and tortuosity is unknown.During the procedure, the non-cordis guidewire, which was already in place at the vasculature of the patient, was back loaded into the distal end port of the nosecone of an outback re-entry cto catheter.The outback advanced over the bifurcation but then had difficulty advancing further into the sfa and it kept getting caught up on the wire.They removed the outback and removed the wire.They tried to reinsert the wire into the guidewire lumen while outside the body, but it would not re-enter.It was reported that there was no foreign material observed in the device.Another outback catheter was opened and inserted into the patient.The deployment of the needle was checked prior to insertion.The new outback was inserted over the same wire and it advanced past the lesion.There was no difficulty deploying the needle and the needle.However, the physician could not reenter the true lumen because of the amount of calcification in the artery.Therefore, the outback was removed and the patient was consulted for surgery.There was no known injury to the patient.The device was returned for evaluation.Upon analysis, a piece of unknown guide wire was found broken inside the guide wire lumen.The reporter indicated that he was unaware of any issue of wire breakage during the procedure.One non-sterile catheter outback was received coiled inside a plastic bag.The cannula was received deployed.There were blood residues observed in the returned device.No kinks or bents were observed in the returned device.The device was flushed however the water did not come out the tip due to obstruction in the gw lumen.Insertion/withdrawal test was performed with lab sample 0.014"gw and the gw was inserted in the cannula guide wire port , however the gw could not be inserted through all the catheter lumen due to an obstruction at 73.0cm from distal tip end , resistance was felt due to obstruction of the gw lumen.The catheter shaft/nosecone spins smoothly as the rhv was rotated.The applicable cannula deployment test was performed and the cannula was fully deployed and retracted without difficulty.Cross sectional analysis was performed to identify the cause of obstruction in the gw lumen.The catheter was cut at 73.0cm from distal tip and 4.0cm of unknown gw was found causing the obstruction in the gw lumen.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The ifu contains the following precautions: if strong resistance is felt during catheter manipulation/delivery, determine the cause of the resistance before proceeding further.Excessive rotation, bending or kinking of the ob-ltd may affect its performance.The failure cannula wire port/guide wire lumen resistance/friction and cannula wire port/guide wire lumen obstructed reported by the customer was confirmed since the gw could not be inserted through the entire catheter lumen due to an obstruction at 73.0cm from distal tip.The obstruction was caused by a 4.0cm piece of unknown guide wire.It is unknown what factors may have contributed to the difficulty initially experienced advancing the outback over the guidewire.It is currently unknown if the guidewire broke during the attempts to introduce the outback inside the patient or during the attempts made by the user to manipulate the wire with the outback outside of the patient as reported.There are vessel characteristics (calcification) that caused the inability of the second outback unit used to re-enter the true lumen as reported.Neither the dhr review nor the product analysis suggests that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Manufacturer Narrative

Updated complaint conclusion: during use of an outback re-entry catheter, it was reported that the device could not advance further into the target vessel and that the outback kept getting caught up on the wire during insertion.After the device was removed and the non-cordis wire was removed, the wire would no longer go through the outback catheter guidewire lumen.They decided to use a second outback.During advancement, it could not reenter the true lumen because of calcification of the arteries.The outback was removed and the patient was consulted for surgery.There was no known injury to the patient.The intended procedure was a right superficial femoral artery (sfa) diagnostic with possible intervention.The target lesion was located in the right superficial femoral artery with an occlusion of the mid sfa with collateral reconstitution.The lesion was heavily calcified and tortuosity is unknown.During the procedure, the non-cordis guidewire, which was already in place at the vasculature of the patient, was back loaded into the distal end port of the nosecone of an outback re-entry cto catheter.The outback advanced over the bifurcation but then had difficulty advancing further into the sfa and it kept getting caught up on the wire.They removed the outback and removed the wire.They tried to reinsert the wire into the guidewire lumen while outside the body, but it would not re-enter.Another outback catheter was opened and inserted into the patient.The deployment of the needle was checked prior to insertion.The new outback was inserted over the same wire and it advanced past the lesion.There was no difficulty deploying the needle.However, the physician could not reenter the true lumen because of the amount of calcification in the artery.Therefore, the outback was removed and the patient was consulted for surgery.There was no known injury to the patient.The device was returned for evaluation.Upon analysis, a piece of unknown guide wire was found broken inside the guide wire lumen.The reporter indicated that he was unaware that a few centimeters of the wire had broken off when he removed it.One non-sterile catheter outback was received coiled inside a plastic bag.The cannula was received deployed.There were blood residues observed in the returned device.No kinks or bents were observed in the returned device.The device was flushed however the water did not come out the tip due to obstruction in the gw lumen.Insertion/withdrawal test was performed with lab sample 0.014"gw and the gw was inserted in the cannula guide wire port, however the gw could not be inserted through all the catheter lumen due to an obstruction at 73.0cm from distal tip end , resistance was felt due to obstruction of the gw lumen.The catheter shaft/nosecone spins smoothly as the rhv was rotated.The applicable cannula deployment test was performed and the cannula was fully deployed and retracted without difficulty.Cross sectional analysis was performed to identify the cause of obstruction in the gw lumen.The catheter was cut at 73.0cm from distal tip and 4.0cm of unknown gw was found causing the obstruction in the gw lumen.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The ifu contains the following precautions: if strong resistance is felt during catheter manipulation/delivery, determine the cause of the resistance before proceeding further.Excessive rotation, bending or kinking of the ob-ltd may affect its performance.The failure cannula wire port/guide wire lumen resistance/friction and cannula wire port/guide wire lumen obstructed reported by the customer was confirmed since the gw could not be inserted through the entire catheter lumen due to an obstruction at 73.0cm from distal tip.The obstruction was caused by a 4.0cm piece of unknown guide wire.It is unknown what factors may have contributed to the difficulty initially experienced advancing the outback over the guidewire.It is currently unknown if the guidewire broke during the attempts to introduce the outback inside the patient or during the attempts made by the user to manipulate the wire with the outback outside of the patient as reported.There are possible vessel characteristics (calcification) that may have caused the inability of the second outback unit used to re-enter the true lumen to treat the cto as reported.Neither the dhr review nor the product analysis suggests that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: OUTBACK RE-ENTRY CATHETER
• Type of Device: CTO CATHETER SYSTEMS (DQY)
• Manufacturer (Section D): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 32580 ; MX 32580
• Manufacturer (Section G): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: aaron goodstein ; miami lakes, FL 33014 ; 63136118
• MDR Report Key: 3703198
• MDR Text Key: 4246637
• Report Number: 9616099-2014-00218
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: OTB42120
• Device Lot Number: 15959294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2014
• Initial Date FDA Received: 03/27/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/10/2014; 05/02/2014; 05/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1