MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 LATEX TEMPERATURE PACING ELECTRODE CATHETER

Model Number	520007P
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had undergone permanent pacemaker operation on (b)(6) 2023 and temporary pacing electrode catheter was used for the procedure.However, the 5fr catheter was not able to pass through the 5fr sheath during the procedure.Per additional information via email from ibc on 19jan2023, there is no patient injury reported.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Additional Manufacturer Narrative
The reported event is inconclusive because no sample was returned and further investigation was not conclusive.A potential root cause for this event could be, incorrect dimensions or material selected.The device was attempted to be used for treatment purposes.It is unknown if the device had met all relevant specifications or resulted in the reported event.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "this device should be used only by or under the supervision of physicians trained in the techniques of transvenous intracardiac studies and temporary pacing." "visually inspect the catheter, under sterile conditions, for kinks in the catheter shaft, integrity of the connector, condition of electrodes, and any other damage." "insertion instructions using a percutaneous introducer sheath 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." 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 device was not returned.
Event or Problem Description
It was reported that the patient had undergone permanent pacemaker operation on (b)(6) 2023 and temporary pacing electrode catheter was used for the procedure.However, the 5fr catheter was not able to pass through the 5fr sheath during the procedure.Per additional information via email from ibc on 19jan2023, there is no patient injury reported.

• Brand Name: LATEX TEMPERATURE PACING ELECTRODE CATHETER
• Common Device Name: TEMPERATURE 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: 16271578
• Report Number: 1018233-2023-00466
• Device Sequence Number: 7492219
• Product Code: LDF
• UDI-Device Identifier: 00801741011535
• UDI-Public: (01)00801741011535
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K800298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,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 Model Number: 520007P
• Device Catalogue Number: 520007P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female