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

Model Number	B2140-040
Medical Device Problem Codes	Break (1069); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.(b)(4).
Event or Problem Description
It was reported that the procedure was to treat the aorta that did not have any tortuosity or calcification.A 14 x 40 mm armada 35 balloon catheter was used and did not meet any resistance during advancement.It was inflated once to nominal pressure without issues.The balloon may have been deflated for less than 5 seconds and was fully deflated without issues.After it was deflated and removed from the anatomy, the balloon was noted to have "peeled off" (lifted off) the catheter; however, the balloon was still attached to the device.It was confirmed under fluoroscopy that no foreign material was left in the anatomy.Additionally, the device did not meet any resistance during removal.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported foreign material 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.It should be noted that the armada 35 instruction for use states: the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.Furthermore, the deflation time for the 14 x 40 mm armada 35 is 30 seconds.In this case, the ifu deviations do not appear to have contributed to this event.The investigation determined the foreign material attached to the proximal seal appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.Attachment: user facility medwatch report number (b)(4).
Event or Problem Description
A user facility medwatch report was received stating: balloon was prepped and used to pre dilate an aortic valve.The balloon did not rupture.When balloon was removed a small plastic piece was hanging.The doctor is not sure if it happened during removal from the sheath/body.No additional information was provided.Returned device analysis revealed that there was foreign material bonded to the proximal seal and that it was lifted away from the outer member.It is most likely that the account was referring to this foreign material when reporting that the balloon was peeled off.
Additional Manufacturer Narrative
This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.Na.

• 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: 9257435
• Report Number: 2024168-2019-13049
• Device Sequence Number: 3934737
• Product Code: LIT
• UDI-Device Identifier: 08717648155598
• UDI-Public: 08717648155598
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup,Followup
• Report Date (Section B): 07/20/2020

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: 01/31/2023
• Device Model Number: B2140-040
• Device Catalogue Number: B2140-040
• Device Lot Number: 90819G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 12/09/2019; 07/20/2020
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 12/30/2019; 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR