MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	B2040-080
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
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.Exemption number e2019001.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified, moderately tortuous superficial femoral artery that was 80% stenosed.The 4.0x80mm armada 35 balloon dilatation catheter was pressurized to nominal pressure.The balloon only partially inflated and a leak was noted from the hub.A new 4.0x60mm armada 35 was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for evaluation.The leak and inflation issue was confirmed.A review of the lot history record identified no nonconforming material records (ncmr).Additionally, there have been no other incidents and/or complaints reported for this lot.The investigation determined that the reported hub 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 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9329855
• Report Number: 2024168-2019-13626
• Device Sequence Number: 398621
• Product Code: LIT
• UDI-Device Identifier: 08717648155109
• UDI-Public: 08717648155109
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2020

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: 07/31/2022
• Device Model Number: B2040-080
• Device Catalogue Number: B2040-080
• Device Lot Number: 90212G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 03/14/2020
• 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: COMMAND GUIDE WIRE
• Patient Age: 80 YR
• Patient Weight: 76