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

Model Number	A2020-080
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2020
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.Na.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion with heavy calcification and moderate tortuosity in the peroneal artery.A command guide wire was advanced to the lesion.Then, a 2 x 80 mm armada 14 balloon catheter was advanced; however, after properly connected the inflation device and inflating the balloon 3 to 4 times at 8 to 10 atmospheres, it was noted that the dye was coming back from the hub.Another unspecified balloon catheter 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
A visual and functional inspections were performed on the returned device and the reported hub leak was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.Potential factors that may contribute to hub leak include, but are not limited to, manufacturing, damage to the sidearm, insufficient/delamination of the adhesive at the inflation lumen/sidearm junction, damage to the inflation lumen or damage to the inner member.The device was prepped prior to use without any leaks noted, which would suggest that the device was not damaged prior to use.The investigation was unable to determine a conclusive cause for the reported leak.It is possible that the guide wire was inadvertently back loaded through the inflation port causing the tear; however, this could not be confirmed.The noted bunched and stretched balloon taper and inner member likely occurred during advancement and retraction through the heavy calcification and moderate tortuosity in the anatomy.The noted chatter marks and kinks on the device likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.

• 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: 10686227
• Report Number: 2024168-2020-08641
• Device Sequence Number: 16286684
• Product Code: DQY
• UDI-Device Identifier: 08717648155970
• UDI-Public: 08717648155970
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K102705
• 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): 12/29/2020

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: 02/28/2023
• Device Model Number: A2020-080
• Device Catalogue Number: A2020-080
• Device Lot Number: 9092741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1