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

Catalog Number	520007P
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid as requested.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 or Problem Description
It was reported that the customer had a complaint on a catheter.Per follow up via phone on 16jul2024, it was reported that the temporary pacing electrode balloon was faulty and would not blow up.
Additional Manufacturer Narrative
The reported event was inconclusive.The conditions of the sample did not allow further evaluation.Visual evaluation of the returned three-photo sample noted one opened (without original packaging), used temporary pacing electrodes with syringe attached.Visual inspection of the three-photo sample noted that the syringe was attach to the inflation valve of the temporary pacing electrodes.The reported failure was unable to be evaluated base off the return photos sample therefore this investigation is considered inconclusive.A potential root cause for this failure mode could be "blocked inflation lumen¿.A dhr review did not show any problems or conditions.The instructions for use were found adequate and state the following: "follow the instructions, warnings, and precautions of the introducer manufacturer.If using a balloon temporary pacing catheter, use half or one french size larger introducer, unless otherwise recommended by the introducer manufacturer.In case of catheters with a balloon, under sterile conditions, remove the protective sheath and inflate the balloon with 1.5 ml of air or carbon dioxide.Use the inflation syringe included in the package.Completely deflate the balloon after the test".Udi format updated with available product information per gudid.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 or Problem Description
It was reported that the customer had a complaint on a catheter.Per follow up via phone on 16jul2024, it was reported that the temporary pacing electrode balloon was faulty and would not blow up.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER
• Common Device Name: 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: 19905904
• Report Number: 1018233-2024-04643
• Device Sequence Number: 7174023
• Product Code: LDF
• UDI-Device Identifier: 00801741011535
• UDI-Public: (01)00801741011535(11)240410(17)260430(10)GFJP0993
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K800298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 520007P
• Device Lot Number: GFJP0993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown