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

Model Number	150NFS35
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire did not seem to be hydrophilic as it did not moved forward.The customer tried 2 devices of the same lot but the guidewires did not move forward.It was stated that they were blocked and it looked like that they were not hydrophilic as it should be.As per additional information via email from ibc on 13feb2023, stated that it was not possible to slide a ureter catheter over the lining wire in question.Initially the user thought of a stent problem, but the second stent gave the same problem, did not slide up.Then the user replaced the liner wire with a new one and now the stent did slide up smoothly.The lining wire felt remarkably stiff/dry.Even after moistening, it was not smooth as it should be.Afterwards the user looked at that particular lining wire again, there were no visible defects, just noticeable.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event is inconclusive as the original complaint samples were not returned.Seven unopened nitinol guidewires were returned without the original packaging.An evaluation was completed by memry corporation.The coating on the returned samples were evaluated and no issues were noted.The samples were noted to be within memry specifications.Though no issues were noted with the coating on the returned samples, as the original complaint samples were not returned, unable to properly evaluate the reported failure.A potential root cause for this event could be, "improper coating formulation/selection, degradation".No manufacturing issues or non-conformances were noted during review of the dhr 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." "do not use dry gauze to manipulate the guidewire as this can damage the surface coating and make the wire tacky." "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." correction: d,h 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 or Problem Description
It was reported that the guidewire did not seem to be hydrophilic as it did not moved forward.The customer tried 2 devices of the same lot but the guidewires did not move forward.It was stated that they were blocked and it looked like that they were not hydrophilic as it should be.As per additional information via email from ibc on 13feb2023, stated that it was not possible to slide a ureter catheter over the lining wire in question.Initially the user thought of a stent problem, but the second stent gave the same problem, did not slide up.Then the user replaced the liner wire with a new one and now the stent did slide up smoothly.The lining wire felt remarkably stiff/dry.Even after moistening, it was not smooth as it should be.Afterwards the user looked at that particular lining wire again, there were no visible defects, just noticeable.

• Brand Name: NITINOL GUIDEWIRE
• Common Device Name: 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: 16436519
• Report Number: 1018233-2023-01194
• Device Sequence Number: 19632975
• Product Code: EZB
• UDI-Device Identifier: 00801741051487
• UDI-Public: (01)00801741051487
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 150NFS35
• Device Catalogue Number: 150NFS35
• Device Lot Number: NGGS4620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown