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

Catalog Number CRU14SA

Device Problem Melted (1385)

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 device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device was returned severly damaged with bunching of the outer catheter and guidewire lumen.The outer catheter was torn near the rapid exchange junction and the guidewire was found bent.The guidewire and inner guidewire lumen were protruding out the distal tip of the catheter.After the catheter was straightened out, the guidewire was removed with resistance.The guidewire and inner guidewire lumen of the recanalization catheter were examined under a microscope and no signs of melting were observed.The investigation is inconclusive as functional testing could not be performed due to poor sample condition.Per the related details, the same user experienced 15 events over a short time period where the guidewire and catheters melted during use, therefore, the user's flowmate injector and generator were replaced and the user has not experienced the issue since.It is likely that the injector and/or generator contributed to the reported event, however, based upon the available information the definitive root cause is unk.

• Brand Name: CROSSER RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): C.R.BARD, INC. (GFO); 289 bay road ; queensbury NY 12804 2045
• Manufacturer Contact: laura hintz ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4905380
• MDR Text Key: 16855580
• Report Number: 2020394-2015-00996
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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?: Yes
• Date Returned to Manufacturer: 05/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 07/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/31/2015
• 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