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

Catalog Number 007417P

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Perforation (2001); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/09/2023

Event Type  Injury  

Event Description

It was reported that in the online survey a physician stated that the patient experienced arrythmia (ventricular tachycardia, ventricular fibrillation), catheter displacement, hemothorax, hematoma, deep vein thrombosis prior to the device placement and catheter displacement, perforation (arterial or cardiac) complications were directly attributable to the device and bleeding was needed for catheter displacement, perforation (arterial or cardiac) in relation to temporary pacing electrode.Medical intervention was unknown.

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.

Manufacturer Narrative

The reported event is inconclusive because no sample was returned for evaluation.A potential root cause for this event could be, "improper inflation volume".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." 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 device was not returned.

Event Description

It was reported that in the online survey a physician stated that the patient experienced arrythmia (ventricular tachycardia, ventricular fibrillation), catheter displacement, hemothorax, hematoma, deep vein thrombosis prior to the device placement and catheter displacement, perforation (arterial or cardiac) complications were directly attributable to the device and bleeding was needed for catheter displacement, perforation (arterial or cardiac) in relation to temporary pacing electrode.Medical intervention was unknown.

• Brand Name: NBIH¿ TEMPORARY PACING ELECTRODE CATHETER
• Type of Device: NBIH¿ 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: 17653290
• MDR Text Key: 322318317
• Report Number: 1018233-2023-06448
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011375
• UDI-Public: (01)00801741011375
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 007417P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• 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