MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER 14S (OTW)

Catalog Number CRUO14SA

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2014

Event Type  malfunction  

Event Description

It was reported that the recanalization catheter melted to the guide wire after one min and 15 seconds of activation in the sfa.The catheter and wire were removed together without incident.Another catheter was used to complete the procedure.There was no reported pt injury.

Manufacturer Narrative

A mfg review was conducted.The lot met all release criteria.This is the first complaint reported for this lot number and issue.The investigation is inconclusive, as the sample was not returned for eval.The definitive root cause could not be determined based upon the available info.It is unk if pt and/or procedural issues contributed to the reported failure.

Manufacturer Narrative

To ensure compliance to 21 cfr 803.50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided.Multiple follow up attempts were made with the user facility to obtain any information pertaining to the patient, product, and/or procedural details (e.G.Date of the event, relevant test data, relevant history, lot #, catalog #, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation.The user facility was able to provide new patient information, which was updated in the appropriate sections.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 14S (OTW)
• 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: 4811437
• MDR Text Key: 16854493
• Report Number: 2020394-2015-00785
• 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,company representative,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2014

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: 10/31/2015
• Device Catalogue Number: CRUO14SA
• Device Lot Number: GFXJ0917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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
• Patient Age: 64 YR
• Patient Weight: 78