MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	B2080-060
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	04/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual analysis was performed on the returned device.The reported balloon rupture and separation was confirmed.The difficulty removing was not tested due to the condition of the device.Cine images were provided and reviewed by an abbott vascular clinical specialist who states: although tortuosity and calcification were reported, the two still images provided were insufficient to determine if these contributed to the failure.One still image documents the presence of residual contrast and a portion of the balloon catheter in the target anatomy following balloon rupture and attempted removal of the device.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 and subsequent treatment was likely due case circumstances.It is likely that the balloon interacted with the moderate to severe calcification causing damage to the outer surface of the balloon material which subsequently ruptured during inflation.Additionally, the difficulty removing, and separation was the result of the ruptured balloon material catching on the introducer sheath.As force was applied during removal, the balloon and inner member separated while being pulled into the introducer sheath.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat lesions in the common iliac and external iliac just past the internal iliac bifurcation with moderate to severe calcification and 50-70% stenosis.No resistance was noted during advancement and balloon angioplasty was attempted with the armada 35 percutaneous transluminal angioplasty (pta) catheter.The balloon was inflated once to 10 atmospheres and ruptured.When the device was attempted to be removed negative pressure was held, and the balloon was stuck in the anatomy.The catheter was able to be removed from the sheath with force; however, the balloon came off the catheter and remained in the vessel.A stent was used to embed the balloon where it was located.The patient is stable.There were no adverse patient sequela 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): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8566276
• Report Number: 2024168-2019-03424
• Device Sequence Number: 19328241
• Product Code: LIT
• UDI-Device Identifier: 08717648155444
• UDI-Public: 08717648155444
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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: 01/31/2022
• Device Catalogue Number: B2080-060
• Device Lot Number: 80808G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 04/30/2019
• 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