MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM; BALLOON FLOW-ASSISTED TEMPORARY PACING ELECTRODE CATHETER

Model Number 006173P

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that damage was found on the balloon of the temporary pacing electrode catheter prior to placement.Per additional information received via email on 19 december 2019 from ibc representative, a small hole was found on the balloon which allegedly caused leaks during pretest.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to an "inappropriate package design".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: "when using a balloon catheter, use care when removing the protective sleeve from the distal portion of the catheter.Forced removal of this protective sleeve may result in damage to the balloon and the catheters structural integrity." h11:section a through f - the information provided by bd represents all of 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 damage was found on the balloon of the temporary pacing electrode catheter prior to placement.Per additional information received via email on 19 december 2019 from ibc representative, a small hole was found on the balloon which allegedly caused leaks during pretest.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM
• Type of Device: BALLOON FLOW-ASSISTED TEMPORARY PACING ELECTRODE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9530469
• MDR Text Key: 179482208
• Report Number: 1018233-2019-08319
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 006173P
• Device Catalogue Number: 006173P
• Device Lot Number: GFDT2481
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1