MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 OEM - BALLOON BIPOLAR TEMPORARY PACING ELECTRODE KIT

Model Number 520007P

Device Problems Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the current of the temporary pacing electrode catheter was not passing.

Manufacturer Narrative

The reported event was confirmed as use-related.Using the multi-meter t-656 and the test box t-657, the resistance was measured for both distal and proximal end of the returned electrode sample.There was no inter-circuit resistance for the distal end of the electrode, and the resistance at the proximal end of the electrode was 1.6 ohms.Therefore, the product failed to meet specifications.The sample was dissected and it was found that the distal tail had been damaged, as seen in gfo evaluation pic attached in the sample evaluation attachments.It appears that the distal leg may have been pulled or stretch causing the damage to the distal wire.The root cause of the reported event is user error in not following the precautions and mishandling the device, resulting in failure to maintain pacing function and requiring replacement of device.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: "this device should be used only by or under the supervision of physicians trained in the techniques of transvenous intracardiac studies and temporary pacing." "excessive bending, torqueing, or kinking of the electrode catheter may cause damage to the catheter including damage to internal wires.".

Event Description

It was reported that the current of the temporary pacing electrode catheter was not passing.

• Brand Name: OEM - BALLOON BIPOLAR TEMPORARY PACING ELECTRODE KIT
• Type of Device: TEMPORARY PACING ELECTRODE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9192301
• MDR Text Key: 168033324
• Report Number: 1018233-2019-06465
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011535
• UDI-Public: (01)00801741011535
• Combination Product (y/n): N
• PMA/PMN Number: K800298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 520007P
• Device Catalogue Number: 520007P
• Device Lot Number: GFDP1317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 DA