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

Model Number 006173P

Device Problem Break (1069)

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

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 when the physician tried to connect the pacer catheter to the pacer box; the black wire that attaches to the black section broke.A new catheter was used to complete the procedure.No medical intervention was reported.

Manufacturer Narrative

The reported event was confirmed.A temporary pacing electrode catheter was returned.A single clamp was attached to a black tail.The clamp was removed and it was found that the black tail was broken.The clamp was attempted to be placed on the non-broken tail with no success.The connection was attempted again and the clamp was able to be connected.A potential root cause could be due to "user error/mistake".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: "1.Inspect the sterile package carefully for damage during transit or storage.Do not use the catheter if the package 2.Visually inspect the catheter, under sterile conditions, for kinks in the catheter shaft, integrity of the connector, condition of electrodes, and any other damage.3.In case of catheters with a balloon, under sterile conditions, remove the protective sheath and inflate the balloon with 1.5 ml of air or carbon dioxide.Use the inflation syringe included in the package.Completely deflate the balloon after the test.".

Event Description

It was reported that when the physician tried to connect the pacer catheter to the pacer box; the black wire that attaches to the black section broke.A new catheter was used to complete the procedure.No medical intervention was reported.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE
• Type of Device: PACING CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8794589
• MDR Text Key: 151300169
• Report Number: 1018233-2019-03947
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011207
• UDI-Public: (01)00801741011207
• Combination Product (y/n): N
• PMA/PMN Number: K800298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 006173P
• Device Catalogue Number: 006173P
• Device Lot Number: GFCR3353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1