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	006172P
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the temporary pacing electrode catheter shaft appears wrinkled inside the blister.Before opening the blister, nurse noticed unusual wrinkled shaft in the catheter.Also stated 2 items of the same reference and lot in the same situation and they were not used.Per follow-up information received via ibc on (b)(6)2023, stated that in the blister, it was normal for the catheter to be rolled up in 2 circles, but not for the it to be wrinkled.In the photo sample, the outer circle of the catheter it makes some "s's", which should not be there.Also stated that was not usual in a catheter that has just been opened and not manipulated.It was normal for it to be straight, just like the inner circle.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the temporary pacing electrode catheter shaft appears wrinkled inside the blister.Before opening the blister, nurse noticed unusual wrinkled shaft in the catheter.Also stated 2 items of the same reference and lot in the same situation and they were not used.Per follow-up information received via ibc on 13-jan-2023, stated that in the blister, it was normal for the catheter to be rolled up in 2 circles, but not for the it to be wrinkled.In the photo sample, the outer circle of the catheter it makes some "s's", which should not be there.Also stated that was not usual in a catheter that has just been opened and not manipulated.It was normal for it to be straight, just like the inner circle.
Additional Manufacturer Narrative
The reported event was confirmed and the cause was unknown.Although a specific cause could not be determined, a potential root cause for this event could be, "inappropriate package design".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "inspect the sterile package carefully for damage during transit or storage.Do not use the catheter if the package is damaged." "visually inspect the catheter, under sterile conditions, for kinks in the catheter shaft, integrity of the connector, condition of electrodes, and any other damage." h11: section a through f - the information provided by bard 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 bard.H3 other text: the actual/suspected device was inspected.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM
• Common Device Name: BALLOON FLOW-ASSISTED BIPOLAR 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: 16206589
• Report Number: 1018233-2023-00167
• Device Sequence Number: 5382583
• Product Code: LDF
• UDI-Device Identifier: 00801741011191
• UDI-Public: (01)00801741011191
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 05/01/2023

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: 09/30/2024
• Device Model Number: 006172P
• Device Catalogue Number: 006172P
• Device Lot Number: GFGV1627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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