MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO OUTBACK ELITE 80CM RE-ENTRY; CATHETER FOR CROSSING TOTAL OCCLUSIONS

Model Number N/A

Device Problems Stretched (1601); Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

One non-sterile outback elite 80cm re-entry unit was received for analysis inside a plastic bag.The unit was unpacked to proceed with the evaluation.During visual review, a wire sgw.014 stabilizer 180cm was also returned but was evaluated under case (b)(4).For the unit of this complaint, the cannula needle was received retracted, an apparent elongation was noted at the end of the strain relief (see microscopical analysis for details) and a portion of the wire was stuck on the distal tip.No other visible anomalies were observed during the analysis.Note: the outback elite catheters are packaged with the cannula deployed.Functional test could not be performed since a portion of a wire was stuck on the distal tip of the unit.Amplified images were taken to a better observation of the anomalies found during visual review.On the first image the stuck wire could be observed.On the second image an elongated portion of shaft could be observed approximately at 79 cm from distal tip (equipment/tooling used: ruler id# cs296; calibration due date, december 8, 2023), however no other characteristics could be noted.A review of the manufacturing documentation associated with lot 17943916, udi# (b)(4) was performed and does not suggest that the failure reported by the customer could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.The reported event by the customer as ¿cannula wire port/guidewire lumen (outback only) ¿ resistance/friction - in patient¿ could not be confirmed since the functional test was not performed due the condition of the unit as received.The exact cause of the conditions found could not be conclusively determined during analysis.The product analysis does not suggest that the event reported could be related to the manufacturing process.No corrective action will be taken at this time since there are no indications that the reported complaint is related to the manufacturing process.Please note that the device in this report is related to a previous report on the stabilizer wire.The manufacturing report number is 1016427-2021-05372.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During a subintimal recanalization, a.014¿ 180cm stabilizer steerable guidewire (sgw) was exchanged from another wire to facilitate the use of an 80cm outback elite re-entry catheter.The outback catheter was inserted over the stabilizer guidewire until it reached the desired position for re-entry.After that, an attempt to retract the stabilizer guidewire from the outback guidewire lumen to exit the needle for the re-entry in the true lumen failed.The tip of the stabilizer guidewire was approximately 9mm outside the distal tip of the outback catheter and did not move further inside.Hence, the stabilizer guidewire and the outback were pulled outside the vessel altogether.Outside the patient and during an inspection of the device, another attempt was made to retract the distal tip of the stabilizer guidewire and it separated.A new.014 stabilizer guidewire and outback re-entry catheter were used to finish the procedure successfully.Analysis of the outback catheter indicates elongation was noted at the end of the strain relief.There was no reported patient injury.Initially, after subintimal crossing of a long occlusion using a guidewire and catheter, a pta balloon was used to predilate the subintimal space as preparation for subintimal recanalization.There was no damage to the outback or packaging before use.All the specified ports of the device were properly flushed.The ports were flushed, followed by a 30 second delay, and then flushed again.The cannula action was verified during prep.The stabilizer guidewire was not kinked or bent and had not been used previously in the procedure.The physician was very experienced in using the outback device, with over 100 cases.No patient information was available.The devices will be returned for evaluation.

Manufacturer Narrative

As reported, during a subintimal recanalization, a.014¿ 180cm stabilizer steerable guidewire (sgw) was exchanged with another wire to facilitate the use of an 80cm outback elite re-entry catheter.The outback catheter was inserted over the stabilizer guidewire until it reached the desired position for re-entry.Once in position, an attempt to retract the stabilizer guidewire into the outback guidewire lumen before extending the catheter tip for re-entry into the true lumen failed.The tip of the stabilizer guidewire was approximately 9mm outside the distal tip of the outback catheter and did not move further inside.Hence, the stabilizer guidewire and the outback were pulled outside the vessel together.Outside the patient and during an inspection of the device, another attempt was made to retract the distal tip of the stabilizer guidewire and it separated.Analysis of the outback catheter indicates elongation was noted at the end of the strain relief.A new.014 stabilizer guidewire and outback re-entry catheter was used to finish the procedure successfully.Initially, after subintimal crossing of a long occlusion using a guidewire and catheter, a pta balloon was used to predilate the subintimal space in preparation of subintimal recanalization.There was no damage to the outback or packaging noted prior to use.All the specified ports of the device were properly flushed, then flushed again after a 30 second delay.The cannula action was verified during prep.The stabilizer guidewire was not kinked or bent and had not been used previously in the procedure.The physician was very experienced in using the outback device, with over 100 cases.There was no reported patient injury.One non-sterile sgw.014 stabilizer 180cm guidewire and one non-sterile outback elite 80cm re-entry catheter was received for analysis.The stabilizer guidewire was analyzed under (b)(4) and the outback elite reentry catheter was analyzed under (b)(4).During visual review of the outback elite re-entry catheter, the cannula tip was received retracted, an elongation was noted at the end of the strain relief and a portion of the stabilizer guidewire was stuck in the distal tip of the catheter.No other visible anomalies were observed during the analysis.Resistance/friction was noted during functional analysis with an impediment to completely advance the wire observed at the height of the elongated portion.Amplified images were taken to observe the anomalies found during visual review.The stuck wire was observed in the first image and an elongated portion of shaft was noted approximately 79 cm from the distal tip in the second image.A product history record (phr) review of lot 17943916 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft)-cto catheter - unraveled/stretched¿ and ¿cannula wire port/guidewire lumen (outback only) ¿ resistance/friction - in patient¿ were confirmed through analysis of the returned devices.However, the exact cause of the failures experienced by the customer could not be conclusively determined during analysis.Based on the limited information available for review, the condition of the unraveled/stretched condition was likely due to procedural/handling factors as evidenced by the elongations noted on the body shaft material.This condition subsequently resulted in the inability to retract the stabilizer guidewire into the outback guidewire lumen.According to the ifu, ¿if strong resistance is felt during catheter manipulation/delivery, determine the cause of the resistance before proceeding further.Consider using a 3¿4 mm balloon at low atm to dilate points of resistance, as needed, along delivery track.If the cause cannot be determined, withdraw the outback® elite re-entry catheter.Excessive rotation, bending or kinking of the outback elite re-entry catheter may affect its performance.¿ neither the product analysis nor the phr review suggests that the failures experienced by the customer could be related to the manufacturing process.Controls are in place to verify the device conditions, and all results were found to be accepted.Therefore, no corrective/preventative actions will be taken at this time.This event is related to a another cordis device submitted under manufacturing report number 1016427-2021-05372.

• Brand Name: OUTBACK ELITE 80CM RE-ENTRY
• Type of Device: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• Manufacturer (Section G): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• Manufacturer Contact: karla castro ; 14201 nw 60th ave,; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12681279
• MDR Text Key: 277933412
• Report Number: 9616099-2021-04996
• Device Sequence Number: 1
• Product Code: PDU
• UDI-Device Identifier: 20705032067567
• UDI-Public: 20705032067567
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K150836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: OTB59080A
• Device Lot Number: 17943916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN PTA BALLOONUNK GUIDEWIREUNK CATHETER; UNKNOWN PTA BALLOONUNK GUIDEWIREUNK CATHETER