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

Catalog Number	006241P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Bacterial Infection (1735)
Date of Event	08/09/2023
Type of Reportable Event	Serious Injury
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
In the online survey a physician stated that the patient experienced perforation (arterial or cardiac) prior to the device placement and pulmonary embolism, bacterial infection in groin complications were directly attributable to the device and pte was needed for pulmonary embolism and groin was needed for infection in relation to 006241p - 6f/125cm semi-floating bipolar/temporary pacing/prot.Pin.It was unknown what medical intervention was reported.
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 ¿product specification & product testing".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: "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." 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
Critical care nurses reported in an online survey that the patient experienced perforation (arterial or cardiac) prior to the device placement and pulmonary embolism, bacterial infection in groin complications were directly attributable to the device and pte was needed for pulmonary embolism and groin was needed for infection in relation to 006241p - 6f/125cm semi-floating bipolar/temporary pacing/prot.Pin.It was unknown what medical intervention was reported.

• Brand Name: TEMPORARY PACING ELECTRODE
• Common Device Name: TEMPORARY PACING ELECTRODE
• 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: 17627532
• Report Number: 1018233-2023-06350
• Device Sequence Number: 15339765
• Product Code: LDF
• UDI-Device Identifier: 00801741011238
• UDI-Public: (01)00801741011238
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 006241P
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: 11/18/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 11/20/2023
• 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