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

Model Number 006173P

Device Problem Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2020

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 the temporary pacing electrode was bent.

Event Description

It was reported that the temporary pacing electrode was bent.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The device did not fail to meet relevant specifications.The product was used for treatment purposes.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.Per glens falls quality engineering (email attached), product would not have scraped a unit with a slight bend/curve at the distal end.This product does soften when heat is applied as well.It is made to be very flexible and still retain some rigidity.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event is unconfirmed a labeling review is not required.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 actual/suspected device was inspected.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM
• Type of Device: BALLOON FLOW-ASSISTED BIPOLAR ELECTRODE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11098289
• MDR Text Key: 224527176
• Report Number: 1018233-2020-22178
• 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: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 006173P
• Device Catalogue Number: 006173P
• Device Lot Number: GFDX4515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other