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

Model Number	B2090-040
Medical Device Problem Codes	Inflation Problem (1310); Product Quality Problem (1506); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
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.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion in an unknown artery.The 9.0x40mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced for post dilatation of a non-abbott stent, however, the device failed to inflate.After removal, the balloon was noted to be separated.There were no reported adverse patient effects and there was no reported significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 and/or complaints from this lot.Based on the information provided, a conclusive cause for the reported inflation problem, difficult to remove and shaft damage could not be determined.It may be possible that the inflation device was not properly connected, or the shaft was bent or kinked causing the inflation lumen to become blocked.Additionally, the difficulty removing, and shaft damage may be the result of the distal shaft being entrapped within the anatomy; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9, h3 - device available for eval updated from "yes" to "no".H6 - medical device problem code 1562 was removed.
Event or Problem Description
Subsequent to the initially filed report the following information was provided: the procedure was to treat the right iliac artery.The balloon did not completely inflate.Resistance was noted during removal and shaft damage occurred.It was confirmed that no separation occurred.The armada 35 was simply pulled to retrieve the balloon from the anatomy.There was no adverse patient effect and there was 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: 12281905
• Report Number: 2024168-2021-06856
• Device Sequence Number: 14413431
• Product Code: LIT
• UDI-Device Identifier: 08717648155475
• UDI-Public: 08717648155475
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111899
• 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): 09/16/2021

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: 07/31/2023
• Device Model Number: B2090-040
• Device Catalogue Number: B2090-040
• Device Lot Number: 00210G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 09/16/2021
• 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: EPIC STENT; EPIC STENT