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

Catalog Number	B2060-250
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G9: exemption number e2019001 - permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that the procedure was to treat a totally occluded de novo lesion located in the right superficial femoral artery.The armada was advanced to the lesion, and when inflated, the balloon ruptured during the first inflation at nominal pressure due to the calcified anatomy.When the delivery system was withdrawn, there was resistance and the balloon came out stretching on the guide wire.A glide catheter was used over the 014 wire to successfully retrieve the balloon.The case was aborted.The patient will be brought back at a later date to complete the procedure.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The balloon and hub were not returned.The reported balloon rupture was unable to be confirmed as the device was returned without the distal balloon end; however, the separation was confirmed.The investigation determined that the reported difficulties were likely due to case related circumstances.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Visual analysis was performed on the returned device.The reported balloon rupture and separation were confirmed.The difficulty removing was not tested due to the condition of the device (balloon and hub were not returned).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.The investigation determined that the reported difficulties were likely due to case related circumstances.It is likely that the balloon rupture was the result of interaction with the totally occluded and calcified lesion causing damage to the outer surface of the balloon material which subsequently ruptured during inflation.The resistance during removal and separation was likely the result of the ruptured balloon material catching on the introducer sheath during removal.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Mfr site - contact name.

• 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: 8795683
• Report Number: 2024168-2019-10095
• Device Sequence Number: 1978524
• Product Code: LIT
• UDI-Device Identifier: 08717648155338
• UDI-Public: 08717648155338
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 11/07/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: B2060-250
• Device Lot Number: 90305G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 09/05/2019; 11/05/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 09/16/2019; 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention