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

Catalog Number CRUO14SA

Device Problems Material Separation (1562); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 11/26/2014

Event Type  malfunction  

Event Description

It was reported that saline did not exit from the tip of the catheter during out of the body test.There was no pt involvement.

Manufacturer Narrative

A further clinical review was performed and identified this event to be mdr reportable pursuant to 21 cfr part 803.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.The tip was examined under magnification (microscope 10x) and the outer catheter had been pulled out from the metal tip and the guidewire lumen had also become separated from the metal tip.Therefore, the investigation is confirmed for material separation.The investigation is inconclusive for device inoperable as functional testing could not be performed due to the material separation.The definitive root cause could not be determined based upon available info.It is unk whether procedural issues contributed to the event.

• 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 204
• Manufacturer Contact: brett curtice ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4811967
• MDR Text Key: 5830706
• Report Number: 2020394-2015-00650
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: CRUO14SA
• Device Lot Number: GFYG0445
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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