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

Model Number	B1080-060
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded.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 similar incidents reported from this lot.The investigation was unable to find a conclusive cause for the reported difficulties.It is possible that user technique in conjunction with challenging lesion characteristics (stenotic area) contributed to the reported difficulties, as the armada balloon possibly conformed to the blockage as designed; however, this cannot be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.
Event or Problem Description
It was reported that this procedure was performed to treat a high grade stenosed and mildly tortuous left av fistula.An armada 35 balloon catheter was inserted into the stenotic area and angioplasty was performed.The balloon was successfully inflated to 17atm and was able to resolve most of the stenotic area.However, after the balloon was fully deflated, it was noted that due to patient anatomy, resistance was felt during removal.The balloon catheter was able to be removed without causing any adverse patient¿s effects.A non-abbott device was then used to treat the rest of the stenotic area.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• 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: 11031949
• Report Number: 2024168-2020-10673
• Device Sequence Number: 667720
• Product Code: LIT
• UDI-Device Identifier: 08717648154874
• UDI-Public: 08717648154874
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

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: 07/31/2023
• Device Model Number: B1080-060
• Device Catalogue Number: B1080-060
• Device Lot Number: 00218G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 59