MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER RECANALIZATION CATHETER

Catalog Number CRU14SA

Device Problems Melted (1385); Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the recanalization catheter melted to the guide wire after approximately two minutes of activation in the tibial.The catheter and wire were removed together without incident.There was no reported pt injury.

Manufacturer Narrative

The lot number for the device has been provided.A review of the device history records is currently being performed.The device has been returned to the mfr for eval.The investigation is currently underway.The info provided by bard represents all of the known info at this time.Despite good faith efforts to obtain additional info, the complainant/ reporter was unable or unwilling to provide any further pt, product, or procedural details to bard.

Manufacturer Narrative

The lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual/microscopic inspection: the catheter was returned severely damaged.Bunching of the outer catheter and guidewire lumen was noted throughout the length of the catheter.The outer catheter was torn near the rapid exchange junction and the guidewire was bent at this location.The guidewire was returned within the inner guidewire lumen and was protruding out the distal tip of the crosser.The distal tip of the introducer sheath was flared, likely indicating retraction issues.Functional/performance evaluation: the guidewire could not be removed from the inner guidewire lumen.The guidewire lumen was straightened out and the guidewire was able to be removed with resistance.Dried blood was observed on the guidewire and a tear was noted in the inner guidewire lumen near the rapid exchange junction.The patency of the distal tip was tested with the returned guidewire and passed without issue.The guidewire and inner guidewire lumen of the crosser were examined under a microscope and no signs of melting were observed.The outer catheter was cut near the distal tip and no twisting of the inner guidewire lumen was noted.No further functional testing could be performed due to the poor sample condition.Medical records review: no medical records have been made available to the manufacturer.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the investigation is inconclusive for the catheter melting to the guidewire, as functional testing could not be performed due to the poor sample condition and no obvious signs of melting were found on the catheter or the guidewire.The guidewire was returned stuck within the catheter.However, the guidewire was able to be removed once the bunching of the inner guidewire lumen was straightened out.The investigation is confirmed for retraction issues, as the crosser catheter was returned within a 6fr introducer sheath and the tip of the sheath was flared.Per the reported event details, there were 15 events from the same user over a short period of time where the guidewires melted to the catheters during activation.The user's flowmate injector and generator were replaced with new units and the problem has not been experienced since.Therefore, it is possible that the flowmate injector and/or the generator contributed to the reported events.However, based upon the available information the definitive root cause is unknown.Labeling review: the crosser catheter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

• Brand Name: CROSSER RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804 2045
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 4905379
• MDR Text Key: 6020073
• Report Number: 2020394-2015-00998
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,hea
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2015

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: 03/31/2017
• Device Catalogue Number: CRU14SA
• Device Lot Number: GFZB2151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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