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

Catalog Number CRE14S

Device Problems Break (1069); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2014

Event Type  malfunction  

Event Description

It was reported that prior to inserting the recanalization catheter into the pt, the catheter would not vibrate.There was no reported pt involvement.

Manufacturer Narrative

A further clinical review of this event was performed and identified the event to be mdr reportable pursuant to 21 cfr part 803.A mfg review was conducted.The lot met all release criteria.This is the only complaint reported to date for corporate lot number gfxl0241.The device was returned with a completely circumferential break was found in the outer catheter, 0.4 cm from the distal tip.The edges of the break wer jagged.The core wire was still intact.There were no other anomalies noted along the length of the catheter.The investigation is confirmed for a break, as a complete circumferential break was observed in the outer catheter near the metal distal tip.The definitive root cause could not be determined based upon available info.It is unk whether procedural issues contributed to the event.The current ifu (instructions for use) states: warnings and precautions: prior to use, the packaging and prod should be inspected for signs of damage.Never use damaged prod or prod from a damaged package.

• Brand Name: CROSSER CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): CR 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: 4811433
• MDR Text Key: 5915681
• Report Number: 2020394-2015-00736
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2014

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: 12/31/2015
• Device Catalogue Number: CRE14S
• Device Lot Number: GFXL0241
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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