MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	1013470-080
Medical Device Problem Codes	Failure to Fold (1255); Defective Device (2588); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.The investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2021, a percutaneous intervention was performed on the right superficial femoral artery (sfa), mildly calcified lesion.An armada dilatation catheter advanced to the lesion without issue and dilatation was performed.During inflation, the proximal shoulder of the balloon, beyond the markers, appeared longer than expected at 10-15mm.The device was removed without issue and a stent placed.The same armada dilatation catheter went to advance; however, resistance during advancement was felt within the sheath.Reportedly, the same armada balloons re-wrap (folding) did not appear normal.The device was removed without issues and another device was successfully used in replacement.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
A visual, dimensional, and functional inspections were performed on the returned balloon catheter and the reported difficulty to advance was unable to be confirmed due to the returned flat condition balloon of the device.The reported marker location issue was unable to be confirmed as the marker was located in the correct location.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.There was no damage noted to the balloon catheter during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.Potential factors for that may contribute to difficulty to advance and cause resistance the introducer sheath (is) include, but are not limited to, manufacturing, incorrect size is used, sheath id, balloon od, damage to the balloon or damage to the is.The investigation was unable to determine a conclusive cause for the reported difficulty to advance the balloon catheter through the introducer sheath, failure to fold and marker location appear to be related to case circumstances of the procedure.In this case, based on the reported information, it is possible that multiple inflations and deflation during the procedure did not allow the balloon to properly refold and/or deflate flat resulting in the difficulty to advance the balloon through the introducer sheath and causing the marker location to appear longer than usual.Blood was noted in the balloon and likely came from blood inside the indeflator or inflation device.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 18 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12632906
• Report Number: 2024168-2021-09227
• Device Sequence Number: 4379837
• Product Code: LIT
• UDI-Device Identifier: 08717648208416
• UDI-Public: 08717648208416
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2021

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: 04/30/2024
• Device Model Number: 1013470-080
• Device Catalogue Number: 1013470-080
• Device Lot Number: 0111141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 85 KG