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

Catalog Number 006225P

Device Problem No Pacing (3268)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2023

Event Type  malfunction  

Event Description

It was reported that a physician in an online survey stated that the device was not successful in ability to pace because "no capture" in relation to the temporary pacing electrode catheter.

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.H3 other text : the device was not returned.

Manufacturer Narrative

The reported event is inconclusive because no sample was returned for evaluation and further evaluation was not conclusive.Although a specific cause cannot be determined, based on the risk document a potential root cause for this event could be, "open circuit or short circuit".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: "inappropriate electrical connections, e.G.Into a wall socket, may pose serious risk of adverse health consequences or death." "please ensure that the catheter is connected as recommended for pacing or measuring intracardiac electrograms." "this device should be used only by or under the supervision of physicians trained in the techniques of transvenous intracardiac studies and temporary pacing." "electrical connections for pacing 1.Insert adapter pin into standard 2 mm (0.080¿) pin receptacle of equipment.If equipment contains a locking mechanism such as a collet or thumbscrew, tighten down onto adapter.Leave affixed to equipment.Warning: inappropriate electrical connections, e.G.Into a wall socket, may pose serious risk of adverse health consequences or death.2.Thread leads of catheter through the adapter eyelet.Connect the negative jack (marked distal) to the negative terminal of the external pulse generator, and the positive jack (unmarked) to the positive terminal of the pulse generator." "excessive bending, torquing, or kinking of the electrode catheter may cause damage to the catheter including damage to internal wires." "inspect the sterile package carefully for damage during transit or storage.Do not use the catheter if the package is damaged." 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 Description

It was reported that a physician in an online survey stated that the device was not successful in ability to pace because "no capture" in relation to the temporary pacing electrode catheter.

• Brand Name: NBIH¿ TEMPORARY PACING ELECTRODE CATHETER
• Type of Device: 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: 17737914
• MDR Text Key: 323300082
• Report Number: 1018233-2023-06749
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 006225P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• 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