MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER

Model Number 006173P

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 05/17/2023

Event Type  malfunction  

Event Description

It was reported that the floating balloon cannot be inflated.As per follow-up information received via (b)(6) on 10feb2023, stated that the device was used on the patient and the patient was exposed to hazardous, blood, or bodily fluids.As per notification received from investigator on 17may2023, it was stated that a tear was noted in the tip of the catheter where the balloon was attached.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.

Manufacturer Narrative

The reported event is confirmed cause unknown.One sample were confirmed to exhibit the reported failure.The device had not met specifications.The product caused the reported failure.The used temporary pacing electrode catheter with attached luer syringe was returned without the original packaging.Visual evaluation of returned sample with no visible defect was noted on the catheter.The balloon was successfully inflated with 1.5cc air using the returned syringe, the stopcock was then closed.After 30 seconds the stopcock was opened and only about 0.7cc was returned to the syringe when passively deflated.Microscopic visual observation: the balloon portion was viewed under the microscope at 25x magnification; no pinholes or signs of a burst were noted; however, a tear was noted of the tip of the catheter where the balloon is attached.A potential root cause for this failure could be ¿improper trimming of balloon".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labelling could not have prevented the reported failure.H11: section a through f - the information provided by bd represents all 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 floating balloon cannot be inflated.As per follow-up information received via ibc on 10feb2023, stated that the device was used on the patient and the patient was exposed to hazardous, blood, or bodily fluids.As per notification received from investigator on 17may2023, it was stated that a tear was noted in the tip of the catheter where the balloon was attached.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER
• Type of Device: TEMPORARY PACING ELECTRODE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17085620
• MDR Text Key: 317442177
• Report Number: 1018233-2023-04093
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011207
• UDI-Public: (01)00801741011207
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K800298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 006173P
• Device Catalogue Number: 006173P
• Device Lot Number: GFCW2342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other