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

Catalog Number CRU14SA

Device Problem Melted (1385)

Patient Problems No Consequences Or Impact To Patient (2199); 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 manufacturer for eval.The investigation is currently underway.

Manufacturer Narrative

The device history records have been 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 with severe bunching of the outer catheter and guidewire lumen.The outer catheter was torn and the inner guidewire lumen was protruding from the outer catheter.The guidewire was returned within the inner guidewire lumen, but was not protruding out the distal tip of the catheter.The guidewire was able to be removed once the bunching of the inner guidewire lumen was straightened out.The investigation is inconclusive, 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.Per the reported event details, there were 15 events from the same user over a short period of time where the guidewire 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.The crosser 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.; tempe AZ
• Manufacturer (Section G): C.R. BARD, INC (GFO); 289 bay rd; queensbury NY 12804 2045
• Manufacturer Contact: laura hintz ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4902751
• MDR Text Key: 19639517
• Report Number: 2020394-2015-00990
• 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

• Date FDA Received: 07/01/2015
• 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: GFZA3440
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2015
• 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