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

Catalog Number	007153P
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
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.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 temporary pacing electrode catheter could not reach an output of more than 15 so no change in the wires was observed and the problem.It was noted that the given lot# was gffs2570.
Event or Problem Description
It was reported that temporary pacing electrode catheter could not reach an output of more than 15 so no change in the wires was observed and the problem.It was noted that the given lot# was gffs2570.Per additional information received 16may2025, stated that the pacing electrode is not capturing despite the output being set to 15; no spike was visualized the generator and connector cable were replaced, but the problem persists.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Sample evaluation results: the returned sample was tested for electrical resistance using test box t-657, calibrated (b)(6) 2026, due 1/2027, multimeter t-402, calibrated (b)(6) 2026, due 1/2027.Both were utilized to test the functionality of both the distal and proximal electrodes.Electrodes look acceptable - no scratches etc.It was observed that co was on the edges of the electrodes, but the working area of the electrodes was noted to not have co and was found to be acceptable.The results of the resistance test are shown below (see figures 1 and 2).Circuit #1 (distal electrode) ¿ 1.4 ohms, circuit #2 (proximal electrode) ¿0.0 ohms.Figure 1: resistance test being performed on the distal electrode.Figure 2: resistance test being performed on the proximal electrode.Note: electrical resistance: per specification resistance must be greater than 0 but less than 30 ohms.Sample evaluation conclusions: results of the sample evaluation indicate that electrical continuity is present in the distal electrode.However, the proximal electrode exhibits a resistance reading consistent with a short circuit.Thus, the review of the catheter indicated the complaint is confirmed; the complaint sample does exhibit the failure condition alleged by the complaint.Investigation summary: review of the sample confirmed the alleged concern.However, based on the available data and the absence of definitive evidence, the cause of the event could not be determined or attributed to manufacturing.Corrections made to tab(s) d and 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 GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 21797385
• Report Number: 1018233-2025-02439
• Device Sequence Number: 7600627
• Product Code: LDF
• UDI-Device Identifier: 00801741011290
• UDI-Public: (01)00801741011290(11)210721(17)260731(10)GFFS2570
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2026

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 007153P
• Device Lot Number: GFFS2570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 04/15/2026; 04/30/2026
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 04/17/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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