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

Catalog Number 006173P

Device Problem Gas/Air Leak (2946)

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

Event Date 11/08/2023

Event Type  malfunction  

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.

Event Description

It was reported that the balloon of the temporary pacing electrode catheter leaked.Per follow-up received on 14nov2023, stated that the product has not entered the human body and is not contaminated with blood or body fluids.

Event Description

It was reported that the balloon of the temporary pacing electrode catheter leaked.Per follow-up received on 14nov2023, stated that the product has not entered the human body and is not contaminated with blood or body fluids.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.Visual evaluation of the returned sample noted one opened (without original packaging), used temporary pacing electrode catheter.Visual inspection of the sample noted using the return syringe the catheter balloon was inflated with 2 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and no leaks observed.No root cause could be found because the reported event was unconfirmed.Dhr is not required since the reported failure was unconfirmed.As the reported event is unconfirmed a labeling review is not required.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 inspected.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER, STAINLESS STEEL ELECTRODES
• Type of Device: TEMPORARY PACING ELECTRODE
• 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: 18236502
• MDR Text Key: 329354776
• Report Number: 1018233-2023-08637
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 006173P
• Device Lot Number: GFHT0132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2023
• 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