MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	A1030-040
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
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
It was reported that the procedure was performed to treat the left tibial artery.The 3.0x40mm armada 14 balloon dilatation catheter was pressurized to the rated burst pressure then a leak was noted from the black strain relief tubing near the hub.Pressure was increased with the indeflator to maintain the pressure in the balloon.The balloon angioplasty was achieved with this balloon.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional analysis was performed on the returned device.The reported leak was confirmed.A review of the lot history record revealed one manufacturing exception potentially related to this complaint.Additionally, a review of the complaint history of the reported lot revealed one other complaint for sidearm leak.Based on the reported information and evaluation of the returned unit, the reported leak appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10925039
• Report Number: 2024168-2020-10015
• Device Sequence Number: 19629903
• Product Code: DQY
• UDI-Device Identifier: 08717648155796
• UDI-Public: 08717648155796
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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 Expiration Date: 07/31/2023
• Device Model Number: A1030-040
• Device Catalogue Number: A1030-040
• Device Lot Number: 0022741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INDEFLATOR; INDEFLATOR
• Patient Age: 73 YR
• Patient Weight: 70