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

Model Number	150NFS35
Medical Device Problem Codes	Accessory Incompatible (1004); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the customer underwent ureterorenolithotripsy procedure on (b)(6)2023 for this procedure, the guidewire was used.When opening the guidewire for the first use, they did not observe anything unusual.In the last step, which was the placement of the double j, a great deal of resistance was noticed, the guide wire was wetted as instructed and even so, the double j did not progress.
Event or Problem Description
It was reported that the customer underwent ureterorenolithotripsy procedure on (b)(6) 2023.For this procedure, the guidewire was used.When opening the guidewire for the first use, they did not observe anything unusual.In the last step, which was the placement of the double j, a great deal of resistance was noticed, the guide wire was wetted as instructed and even so, the double j did not progress.
Additional Manufacturer Narrative
The reported event is inconclusive because no sample was returned for evaluation and further investigation was not conclusive.Though a specific cause cannot be determined, a potential root cause for this event could be, "hydrophylic coating too slick".The device was used for treatment purposes.It was unknown if the device had met all relevant specifications or resulted in the reported event.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.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." "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." "do not advance or withdraw a guidewire when resistance is encountered as perforation could occur." 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 device was not returned.

• Brand Name: NICORE 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: 16451978
• Report Number: 1018233-2023-01271
• Device Sequence Number: 5416904
• Product Code: EZB
• UDI-Device Identifier: 00801741051487
• UDI-Public: (01)00801741051487
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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: NGGT4420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• 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