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

Catalog Number	006225P
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that in an online survey, a physician stated that no, they were not able to successfully place the electrode (ability to place electrode) because of an emergency case in relation to 006225p-5f/115cm semi-floating bipolar/temporary pacing/prot.Pin.
Additional 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 device history record review could not be performed without a lot number.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 or Problem Description
It was reported that in an online survey, a physician stated that no, they were not able to successfully place the electrode (ability to place electrode) because of an emergency case in relation to 006225p-5f/115cm semi-floating bipolar/temporary pacing/prot.Pin.

• Brand Name: SEMI-FLOATING TEMPORARY PACING ELECTRODE CATHETER, BIPOLAR
• Common Device Name: 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: 17775519
• Report Number: 1018233-2023-06873
• Device Sequence Number: 18000536
• Product Code: LDF
• UDI-Device Identifier: 00801741011221
• UDI-Public: (01)00801741011221
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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 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: 08/28/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 12/15/2023
• 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: Unknown