MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER, STAINLESS STEEL ELECTRODES

Catalog Number 006173P

Device Problem Failure to Infuse (2340)

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

Event Date 09/06/2023

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.H3 other text : the device was not returned.

Event Description

It was reported that the balloon of the temporary pacing electrode catheter could not be opened.

Manufacturer Narrative

The reported event was inconclusive since no sample return for evaluation.A potential root cause for this failure could be "non-functional electrode(s), procedure delay due to inability to pace".Potential causes of failure: operator error, incorrect electrode dimensions, wrong crimper jaws used, equipment malfunction, operator error, handling, crimp machine out of adjustment or malfunctioning, splice machine out of adjustment or malfunctioning, splice band material defective, no continuity, splice bands/circuit wires touching within mold, circuit wires touching within shaft, broken wires caused by: incorrect molder settings, improper placement of bifurcation into mold, handling, improper splice / improper contact between circuit wire and electrodes & broken wires, non-stripped wires, loose crimp.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: "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." 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 balloon of the temporary pacing electrode catheter could not be opened.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER, STAINLESS STEEL ELECTRODES
• Type of Device: 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: 17911996
• MDR Text Key: 325382895
• Report Number: 1018233-2023-07338
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011207
• UDI-Public: (01)00801741011207
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K800298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 006173P
• Device Lot Number: GFHR2261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2023
• 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