MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 NICORE NITINOL GUIDEWIRE

Catalog Number 150NSS35

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 guidewire was broken when pulling out.Per follow-up information received from ibc on 06sep2023, stated that there was no broken piece was found in patient body.

Manufacturer Narrative

The reported event is confirmed cause unknown.Visual evaluation of the returned photo sample noted one opened (without original packaging), used nitinol guidewire.Visual inspection of the photo sample noted the tip of the guidewire is piercing out of the coating.This does not meet specification per inspection procedure which states "no components are to be missing, incorrect, or damaged.A potential root cause for this failure mode could be ¿material selection, device design, degradation¿.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: "warning: 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 reshape the guidewire by any means.Attempting to reshape the guidewire may cause damage resulting in release of fragments into the urinary tract.Failure to exercise proper caution 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.Failure to comply with the warnings could result in damage to the guidewire to include, but not limited to: wire breakage, abrasion of the coating, release of guidewire fragments into the urinary system, all of which might require intervention." correction: e.H11: section a through f - the information provided by bd represents all 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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the guidewire was broken when pulling out.Per follow-up information received from ibc on 06sep2023, stated that there was no broken piece was found in patient body.

• Brand Name: NICORE NITINOL GUIDEWIRE
• Type of Device: NICORE NITINOL GUIDEWIRE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17763854
• MDR Text Key: 323588967
• Report Number: 1018233-2023-06838
• 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: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 150NSS35
• Device Lot Number: NGHP1214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2023
• 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 Outcome(s): Other