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

Model Number	A2030-120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded and will not return for analysis.Investigation is not complete.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2021, a percutaneous intervention was performed on the right peroneal artery lesion.Pre-dilatation was successfully performed using armada catheters and a 4.0x18mm xience alpine stent was successfully implanted.Angioplasty was then performed using armada dilatation catheters in the dorsalis pedal artery with subtotal occlusion.Following use of armada (a2030-120, 0112541), a thrombus/embolism was observed in the proximal pedal artery, successfully treated with a thrombectomy.The event resolved without sequela.Reportedly, there was no device malfunction.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.In this case, there was no reported device malfunction associated with the armada 14 balloon catheter.The reported patient effect of embolism is listed in the armada 14 instruction for use as a known potential complication that may occur.Based on the case information, a conclusive cause for the reported patient effect(s) resulting in unexpected medical intervention, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.E1, e3.

• 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: 12051970
• Report Number: 2024168-2021-05338
• Device Sequence Number: 3427267
• Product Code: DQY
• UDI-Device Identifier: 08717648156106
• UDI-Public: 08717648156106
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: A2030-120
• Device Catalogue Number: A2030-120
• Device Lot Number: 0112541
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 07/21/2021
• 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: XIENCE ALPINE STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 86