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

Catalog Number	006225P
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
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.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 critical care physician in the online survey stated that the patient experienced an adverse event directly attributable to the temporary pacing electrode and the patient experienced arrythmia (ventricular tachycardia, ventricular fibrillation), perforation (arterial or cardiac) and pulmonary embolism.This resulted in the patient injury requiring medical or surgical intervention.Per additional information received via email on 04jun2024, physician also indicated catheter displacement occurred after temporary pacing electrode catheter placement.The physician indicated this complication to be a procedure related complication.
Additional Manufacturer Narrative
The reported event is inconclusive because no sample was returned for evaluation and further investigation was not conclusive.A potential root cause for this failure mode could be "balloon failure /degradation".Based on information in the fmea, the residual risk of this failure is low.Current controls in place are adequate to mitigate this failure mode.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "the risks of using temporary pacing catheters include those risks related to heart catheterization, such as thromboembolism, perforation, tamponade, and infection.The induction of an unintended arrhythmia is a known complication.This device should be used only by or under the supervision of physicians trained in the techniques of transvenous intracardiac studies and temporary pacing.This device is for one time use only.Reuse or resterilization can impair the structural integrity and/or performance of the catheter.Adverse patient reactions can also result from reuse.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." 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 critical care physician in the online survey stated that the patient experienced an adverse event directly attributable to the temporary pacing electrode and the patient experienced arrythmia (ventricular tachycardia, ventricular fibrillation), perforation (arterial or cardiac) and pulmonary embolism.This resulted in the patient injury requiring medical or surgical intervention.Per additional information received via email on 04jun2024, physician also indicated catheter displacement occurred after temporary pacing electrode catheter placement.The physician indicated this complication to be a procedure related complication.

• Brand Name: SEMI-FLOATING TEMPORARY PACING ELECTRODE CATHETER, BIPOLAR
• 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: 19593064
• Report Number: 1018233-2024-03698
• Device Sequence Number: 12893099
• Product Code: LDF
• UDI-Device Identifier: 00801741011221
• UDI-Public: (01)00801741011221
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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 Catalogue Number: 006225P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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