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

Catalog Number	B2070-200
Medical Device Problem Codes	Deflation Problem (1149); Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The supera stent is filed under a separate medwatch report number.Evaluation summary: a visual inspection was performed on the returned device.The reported balloon/marker separations were confirmed.The deflation issue was unable to be confirmed due to the returned condition of the device.The reported entrapment of the device with the stent was unable to be replicated in a testing environment as it was based on operational circumstances.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.It should be noted that the instructions for use (ifu), pta, (b)(6): deflate the balloon by aspirating the inflation syringe or inflation device.The investigation determined the reported difficulties and subsequent damaged to the balloon dilatation catheter (bdc) appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a chronic total occlusion of the right superficial femoral artery.The access site was the right common femoral artery.An unspecified supera stent was implanted at the lesion and post-dilatation was performed with a 7.0 x 200 mm armada 35 balloon dilatation catheter (bdc).The armada bdc did not meet any resistance during advancement; however, deflation time was insufficient and a waist occurred in the balloon because the distal part still had contrast inside it.The top half of the balloon deflated fast; however, removal of the balloon was started before the rest of the balloon had fully deflated.Therefore, the balloon separated into two separate pieces.Part of the balloon was inside the supera stent and the other part was inside the introducer sheath.The device was removed with the introducer sheath to remove half of the balloon, and the other half that was inside the supera stent was removed via cut-down procedure.The supera stent was not damaged by the armada 35 bdc; however, the stent was also removed to remove the remaining half of the armada balloon.The distal markers that separated as well were also removed via cut-down.The lesion was noted to be patent; therefore, no further treatment was done.Angiography was performed which confirmed that the patient was stable.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: 7938405
• Report Number: 2024168-2018-07699
• Device Sequence Number: 16593706
• Product Code: LIT
• UDI-Device Identifier: 08717648155413
• UDI-Public: 08717648155413
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/05/2018

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: 02/29/2020
• Device Catalogue Number: B2070-200
• Device Lot Number: 60928G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/05/2018
• 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: STENT: SUPERA
• Outcome Attributed to Adverse Event: Required Intervention