MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 NITINOL CORE GUIDEWIRE, .035", 3 CM, STRAIGHT, STIFF, 150 CM LENGTH

Model Number 150NSS35

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.A nicore nitinol guidewire was returned opened in its original packaging.Approximately 1/8 of an inch of nitinol wire was exposed at the proximal end.No evidence of kinking was present, but the jacketing had been stripped away.Nitinol wire is exposed; the wire appears to have been forcibly stripped of its jacketing.According to the supplier evaluation, "there is no evidence of kinking of the guidewire.However, nitinol wire is exposed; the wire appears to have been forcibly stripped of its jacketing.This was probably caused during removal of the wire from the tube and not at memry¿s facility.This root cause was only probable as the actual method, location, and time of the stripping cannot be definitively determined".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "inspect all guidewires for damage prior to use.Bending or kinking during or prior to placement could damage the guidewire.Do not attempt to use the guidewire if it has been damaged.Use of a damaged wire may result in damage to the urinary tract.Do not manipulate or remove the guidewire through a metal cannula or needle.This may result in destruction/separation of the outer jacket of the wire requiring retrieval.".

Event Description

It was reported that there were kinking signs at the tip of the guidewire.Per follow-up with ibc representative on 22jul2020, no additional information was available.

• Brand Name: NITINOL CORE GUIDEWIRE, .035", 3 CM, STRAIGHT, STIFF, 150 CM LENGTH
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 10765385
• MDR Text Key: 214800425
• Report Number: 1018233-2020-06332
• Device Sequence Number: 1
• Product Code: EZB
• UDI-Device Identifier: 00801741051524
• UDI-Public: (01)00801741051524
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2024
• Device Model Number: 150NSS35
• Device Catalogue Number: 150NSS35
• Device Lot Number: NGDP2008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2019
• 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