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
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that there was kinking on the proximal segment of the pacing lead.
Event or Problem Description
It was reported that there was kinking on the proximal segment of the pacing lead.
Additional 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
• Common Device Name: 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
• Report Number: 1018233-2020-00393
• Device Sequence Number: 16875729
• Product Code: LDF
• UDI-Device Identifier: 00801741011238
• UDI-Public: (01)00801741011238
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 006241P
• Device Catalogue Number: 006241P
• Device Lot Number: GFDR2717
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/25/2019
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1