MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 4FR 110CM; TEMPORARY PACING ELECTRODE CATHETER

Model Number	006172P
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Perforation (2001); Pericardial Effusion (3271)
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.The device was not returned.
Event or Problem Description
It was reported that a minimum of 5 times since the end of 2017, providers who had been using the device had instances of the tip of the catheter puncturing the wall of the heart, which caused cases of pericardial effusion.In none of the instances staff kept the packaging or any piece of the cardiac catheter kit.Providers requested a new type of catheter device, and when they began to use it, the problem subsided.The new catheter kits they used eventually ran out of stock, which caused them to go back to and use the original ones, and this caused problems for patients.At the end of 2019, after switching back to the bard medical catheters, a provider had another problem with the device.The cardiac catheter lab staff were attempting to place the device during a cardiac procedure in (b)(6) for an (b)(6) female.Per additional information received 24jan2020 from the complainant, the end of the catheter was alleged to be to hard/rigid, which caused the tip of the catheter to puncture the inner walls of the heart.
Event or Problem Description
It was reported that a minimum of 5 times since the end of 2017, providers who had been using the device had instances of the tip of the catheter puncturing the wall of the heart, which caused cases of pericardial effusion.In none of the instances staff kept the packaging or any piece of the cardiac catheter kit.Providers requested a new type of catheter device, and when they began to use it, the problem subsided.The new catheter kits they used eventually ran out of stock, which caused them to go back to and use the original ones, and this caused problems for patients.At the end of 2019, after switching back to the bard medical catheters, a provider had another problem with the device.The cardiac catheter lab staff were attempting to place the device during a cardiac procedure in december for an 81 year old female.Per additional information received 24jan2020 from the complainant, the end of the catheter was alleged to be to hard/rigid, which caused the tip of the catheter to puncture the inner walls of the heart.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential root cause could be due to " inappropriate material specification".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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 of 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.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 4FR 110CM
• Common Device Name: TEMPORARY PACING ELECTRODE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9706799
• Report Number: 1018233-2020-01005
• Device Sequence Number: 11598571
• Product Code: LDF
• UDI-Device Identifier: 00801741011191
• UDI-Public: (01)00801741011191
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K800298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 006172P
• Device Catalogue Number: 006172P
• Device Lot Number: GFDW3504
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 81 YR