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

Catalog Number 006173P

Device Problem Inflation Problem (1310)

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

Event Date 01/23/2024

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 temporary pacing electrode catheter cuff could not be filled.The event occurred before use on the patient.The customer wanted to fill the cuff with air to test the function, but it was determined that it was not possible.

Manufacturer Narrative

The reported event was unconfirmed.Visual evaluation of the returned sample noted one opened (with original label), used temporary pacing electrode catheter.Visual inspection of the sample noted using the luer lock catheter balloon was inflated with 1.5 cc air, stopcock closed syringe removed.Allowed to rest with no leaks noted for one minute.The balloon inflated with no issues, stopcock opened, and balloon deflated.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.

Event Description

It was reported that the temporary pacing electrode catheter cuff could not be filled.The event occurred before use on the patient.The customer wanted to fill the cuff with air to test the function, but it was determined that it was not possible.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER, STAINLESS STEEL ELECTRODES
• 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: 18675790
• MDR Text Key: 335010452
• Report Number: 1018233-2024-00609
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• 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: GFHW2299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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