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 Problems Inflation Problem (1310); Failure to Infuse (2340)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

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 foley catheter balloon could not be inflated.This happened for the second time within 2 months.Stated that the balloon could only be inflated when user let in at higher volume.It was like clogged, so it was more sticking which was then lifted.Additional information received on 24-june-2021, when the catheter was tested before it was inserted, it was found that the balloon could not be inflated.The same problem was reported on (b)(6) 2021.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The device did not fail to meet relevant specifications.Based on the reported event it is unknown if the product was used for diagnostic or treatment purposes.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.The lot number is unknown; therefore, the device history record could not be reviewed.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 evaluated.

Event Description

It was reported that the temperature pacing electrode balloon could not be inflated.This was the second time within 2 months this happened.Stated that the balloon could only be inflated when you let in a higher volume.It was like clogged, so it was more of a sticking that was then lifted.

• 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: 12170404
• MDR Text Key: 261679000
• Report Number: 1018233-2021-04217
• 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: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 006173P
• Device Catalogue Number: 006173P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other