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

Catalog Number 150NFS35

Device Problems Break (1069); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the hydrophilic guide was separated in two at the time of being used in a surgical procedure.Per additional information from the ibc via email (b)(6) 2019, there was no patient injury, and no medical intervention was required.

Manufacturer Narrative

The reported event was confirmed, as the cause was unknown.Evaluation report of the returned sample, submitted by memry corporation, stated that approximately 5¿ of jacketing was peeled away exposing the underlying nitinol wire.Visual examination of the jacketing under 10x magnification showed a clean cut similar to have been cut by a razor.Examination of the tubing showed no sharp edges or burrs.When a sample of coated wire was tested for coefficient of friction (cof), the results were found to be within specification.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: ¿direction for use: the physician should select the proper size and length of the guidewire for the procedure being performed.1.The guidewire is packaged in a protective coil.Hydrophilic coated guidewires require activation of their coating.Prior to removing the guidewire from the protective coil, inject sterile saline through the port to activate the lubricious coating.Remove the guidewire from the protective coil and carefully inspect the guidewire for separation, bends, kinks or a damaged tip.2.Introduce the guidewire, flexible end first, into the working channel of the endoscopes or percutaneously into the urinary tract.3.Advance the guidewire slowly into the desired position.Continuously confirm guidewire position either visually or under fluoroscopy.4.Carefully withdraw the guidewire taking care not to kink.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and with applicable local, state and federal laws and regulations." correction: d10, h3.H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that the hydrophilic guide was separated in two at the time of being used in a surgical procedure.Per additional information from the ibc via email 02dec2019, there was no patient injury, and no medical intervention was required.

• Brand Name: NITINOL CORE GUIDEWIRE, .035", 3 CM, STRAIGHT, STANDARD, 150 CM LENGTH
• Type of Device: NITINOL GUIDEWIRE, STANDARD SHAFT, STRAIGHT TIP
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9460503
• MDR Text Key: 178122223
• Report Number: 1018233-2019-07927
• Device Sequence Number: 1
• Product Code: EZB
• UDI-Device Identifier: 00801741051487
• UDI-Public: (01)00801741051487
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/05/2024
• Device Catalogue Number: 150NFS35
• Device Lot Number: NGDQX203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1