MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 COURNAND SEMI-FLOATING TEMPORARY PACING ELECTRODE, 6FR 125CM; SEMI-FLOATING BIPOLAR PACING ELECTRODE CATHETER

Model Number 006241P

Device Problems Deformation Due to Compressive Stress (2889); Material Deformation (2976)

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

Event Date 11/18/2019

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 there was kinking on the proximal segment of the pacing lead.

Event Description

It was reported that there was kinking on the proximal segment of the pacing lead.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.The potential root cause could be due to " 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: "excessive bending, torquing, or kinking of the electrode catheter may cause damage to the catheter including damage to internal wires.This device is for one time use only.Reuse or resterilization can impair the structural integrity and/or performance of the catheter." 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.

• Brand Name: COURNAND SEMI-FLOATING TEMPORARY PACING ELECTRODE, 6FR 125CM
• Type of Device: SEMI-FLOATING BIPOLAR PACING ELECTRODE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9601998
• MDR Text Key: 180401885
• Report Number: 1018233-2020-00393
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011238
• UDI-Public: (01)00801741011238
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 006241P
• Device Catalogue Number: 006241P
• Device Lot Number: GFDR2717
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1