MAUDE Adverse Event Report: ABBOTT VASCULAR RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER; PEREIPHERAL DILATATION CATHETER

Model Number	1008193-20
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
User facility medwatch report states [mw5099757]: [an rx viatrac 14mm plus peripheral dilation catheter was being utilized during a peripheral angioplasty, 4-5 mm of air had been instilled when the balloon burst leaving a fragment of the device in the patient.Is therapy still on-going? no.Peripheral angioplasty.Fda safety report id# (b)(4)] no additional information was provided.
Additional Manufacturer Narrative
Additional information was received reporting that this event is a duplicate of mfr #2024168-2021-02879-01; therefore, no investigation is required.Investigation results were filed under the duplicate event medwatch report, mfr#2024168-2021-02879-01.
Event or Problem Description
Subsequent to filing the initial report, it has been confirmed that this event is a duplicate of mfr#2024168-2021-02879-01.

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Common Device Name: PEREIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11657152
• Report Number: 2024168-2021-03066
• Device Sequence Number: 3610119
• Product Code: LIT
• UDI-Device Identifier: 08717648056987
• UDI-Public: 08717648056987
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K072798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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: 07/31/2022
• Device Model Number: 1008193-20
• Device Catalogue Number: 1008193-20
• Device Lot Number: 0080362
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/03/2021
• 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: Other
• Patient Age: 49 YR
• Patient Weight: 109