MAUDE Adverse Event Report: CORDIS CORPORATION VISTA BRITE TIP IG INTRODUCER GUIDING CATHETERS; ENDO GUIDING CATHETERS (DQY)

Catalog Number 4038553C

Device Problem Device Rinsing Issue (2309)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but has not yet been received.Additional info is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, during surgery the physician had a problem rinsing the vista brite tip guiding catheter.The physician removed something strange from the sheath which prevented the rinse of the sheath.There was no report of patient injury.The device will be returned for analysis.

Manufacturer Narrative

As reported, during the procedure, the physician had a problem rinsing the vista brite tip guiding catheter.The physician removed something strange from the sheath which prevented the rinse of the sheath.There was no report of patient injury.There is no further information available.The device is not available for analysis.The device was not returned for analysis.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.Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.According to the instructions for use (ifu), users are cautioned to keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Neither the dhr nor the information available for review indicate that there is a design or manufacturing related issue, therefore no corrective or preventative action is required.

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

Analysis of the returned device indicated one non sterile unit intro g 8f contra 55cm.035" was received coiled inside a plastic bag.Vessel dilator was received inserted in the sheath.A piece of teflon was observed stuck in the hub.No other issues were found.According to procedure, functional test (flushing) was performed without problem.During microscopic analysis no damages were observed into hub.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 reported by the customer as ¿catheter (body/shaft) - obstructed-in patient: particles can be/were injected (peripheral)" was not confirmed since functional test was performed without problem; however a piece of teflon was observed stuck in the hub.The root cause could not be conclusively determined.The pet team determined that current manufacturing controls are in place to detect delamination; ¿braided wire transfer (100% inspection)¿ and ¿brite tip inspection (100%)¿ and subassemblies inspection.Per product dhr review, it showed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Based on the investigation it can be concluded that complaint root cause is an isolated event and is not manufacturing related, for this reason no further actions will be taken.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, during the procedure, the physician had a problem rinsing the vista brite tip guiding catheter.The physician removed something strange from the sheath which prevented the rinse of the sheath.There was no report of patient injury.There is no further information available.The device is not available for analysis.One non sterile unit intro g 8f contra 55cm.035" was received coiled inside a plastic bag.Vessel dilator was received inserted in the sheath.A piece of teflon was observed stuck in the hub.No other issues were found.Functional test (flushing) was performed without any problems.During microscopic analysis, no damages were observed in the hub; however the catheter was cut lengthwise and examined inside with the pet team (csi and gc) and damages were observed in the catheter.The unit was sent to ftir analysis in order to analyze the foreign material found.Based on the absorption bands observed in the ir spectra, one can conclude that both the reference and the foreign material are composed of ptfe (polytetrafluoroethylene).The unit was sent to sem analysis in order to analyze the potential cause of the internal damages.Results showed that there is evidence of scratching in the internal surface which also caused damaged to braidwire.Additionally, there is clear evidence of interaction between the internal ptfe and an unknown object which caused the accordioned-like condition and ptfe delamination.The exact cause could not be conclusively determined.No other issues were found.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 event reported by the customer as ¿catheter (body/shaft) - obstructed-in patient: particles can be/were injected (peripheral)" was not confirmed since functional testing was performed without any issues.According to the instructions for use (ifu), users are cautioned to keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.The exact cause of the reported event could not be conclusively determined.Neither the device history record (dhr) review nor the product analysis suggests that the event is related to the manufacturing process.Therefore no corrective or preventative actions will be taken.The event reported by the customer as ¿catheter (body/shaft) - foreign material-during prep" was confirmed since a piece of teflon was observed stuck in the hub.The root cause could not be conclusively determined.Procedural/handling factors appear to have impacted the event experienced by the customer as evident by scratches in the internal surface of the cannula which also caused damage to the braid wire.According to the product instructions for use, users are instructed to insert the vessel dilator through the csi¿s hemostasis valve, snapping it into place at the hub followed by a flush with heparinized saline or suitable isotonic solution, as was done in this procedure.Neither the dhr review nor the product analysis suggests that the event is related to the manufacturing process.Therefore no corrective or preventative actions will be taken.

• Brand Name: VISTA BRITE TIP IG INTRODUCER GUIDING CATHETERS
• Type of Device: ENDO GUIDING CATHETERS (DQY)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5309837
• MDR Text Key: 34607184
• Report Number: 9616099-2015-00663
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K001136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 4038553C
• Device Lot Number: 17195806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1