MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE RX PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U42001H4RX
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/16/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: (b)(6) 2022).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.
Event or Problem Description
It was reported that during an angioplasty procedure in the left anterior tibial artery via right femoral artery, the pta balloon catheter allegedly had retraction difficulties and detached inside the patient.Reportedly, attempts were made via balloons inflations and/or snaring for retrieval of catheter within the patient¿s left leg.After two hours, decision was made to send patient to surgery for removal of the balloon.The detached segment was removed during surgery, however, the patient expired two days post-surgery.

• Brand Name: ULTRAVERSE RX PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9720521
• Report Number: 2020394-2020-01025
• Device Sequence Number: 18921191
• Product Code: LIT
• UDI-Device Identifier: 00801741055881
• UDI-Public: (01)00801741055881
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2020

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 Model Number: U42001H4RX
• Device Catalogue Number: U42001H4RX
• Device Lot Number: CMDU0487
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/18/2020
• 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: Death
• Patient Age: 86 YR
• Patient Weight: 63