MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 NBIH¿ TEMPORARY PACING ELECTRODE CATHETER

Catalog Number	007153P
Medical Device Problem Code	No Pacing (3268)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was no current output after connecting the temporary pacemaker, and they changed to a new one.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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 or Problem Description
It was reported that there was no current output after connecting the temporary pacemaker, and they changed to a new one.
Additional Manufacturer Narrative
The reported event was unconfirmed.Review of the sample indicates that the alleged concern does not exist.Both electrodes tested within spec, there was no damage to the catheter.Thus, the complaint is unconfirmed.Root cause summary: review of the sample shows the complaint does not exist.The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Process failure mode: ¿ electrical short ¿ electrical non- continuities ¿ switched tails potential causes of failure: ¿ splice bands/circuit wires touching within mold ¿ broken wires caused by: incorrect molder settings, improper placement of bifurcation into mold, handling, defective purchased tail ¿ operator error at mpa123, a146 (splice tail) 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: precautions: ¿ excessive bending, torquing, or kinking of the electrode catheter may cause damage to the catheter including damage to internal wires.Inspection instructions: visually inspect the catheter, under sterile conditions, for kinks in the catheter shaft, integrity of the connector, condition of electrodes, and any other damage.Electrical connections for pacing: 1.Insert adapter pin into standard 2 mm (0.080¿) pin receptacle of equipment (see figure 1).If equipment contains a locking mechanism such as a collet or thumbscrew, tighten down onto adapter.Leave affixed to equipment.Warning: inappropriate electrical connections, e.G., into a wall socket, may pose serious risk of adverse health consequences or death.2.Thread leads of catheter through the adapter eyelet.Connect the negative jack (marked distal) to the negative terminal of the external pulse generator, and the positive jack (unmarked) to the positive terminal of the pulse generator.Correction: d, h udi format updated with available product information per gudid.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.

• Brand Name: NBIH¿ TEMPORARY PACING ELECTRODE CATHETER
• Common Device Name: TEMPORARY PACING ELECTRODE CATHETER
• 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: 19975405
• Report Number: 1018233-2024-04811
• Device Sequence Number: 8387196
• Product Code: LDF
• UDI-Device Identifier: 00801741011290
• UDI-Public: (01)00801741011290(11)220824(17)270831(10)GFGT3108
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/31/2024

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 Catalogue Number: 007153P
• Device Lot Number: GFGT3108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• 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