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

Model Number	B2050-060
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet complete.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 right iliac artery.A 8x20mm armada 35 balloon was advanced to the lesion and inflated once, when the balloon ruptured at 8 atmospheres.When removing the device, it got stuck on the guide wire.The physician kept pulling against resistance, when the device separated and came out.Angiography noted that the distal portion (including distal marker and half of balloon) remained in the anatomy.The buddy wire technique was performed to remove the separated portion successfully.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat a right iliac artery.A 8x20mm armada 35 balloon was advanced to the lesion and inflated once, when the balloon ruptured at 8 atmospheres.When removing the device, it got stuck on the guide wire.The physician kept pulling against resistance, when the device separated and came out.Angiography noted that the distal portion (including distal marker and half of balloon) remained in the anatomy.The buddy wire technique was performed to remove the separated portion successfully.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.Subsequent to filing the initial mdr, the following information was received: device analysis noted a 300 cm length supra core guide wire was received frozen inside the balloon catheter with bent core.The account confirmed the supra core guide wire was used alongside the armada balloon.
Additional Manufacturer Narrative
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.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 revealed no other incidents and/or complaints reported for this lot.The investigation determined that the reported difficulties were likely due to case related circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The supra core guide wire referenced in b5 and d11 is being filed under a separate medwatch report number.Device code 2017 was removed.

• 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: 10257710
• Report Number: 2024168-2020-05657
• Device Sequence Number: 3484625
• Product Code: LIT
• UDI-Device Identifier: 08717648155185
• UDI-Public: 08717648155185
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 07/28/2020

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: 04/30/2023
• Device Model Number: B2050-060
• Device Catalogue Number: B2080-020
• Device Lot Number: 91104G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 07/28/2020
• 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: BUDDY WIRE; HT SUPRACORE GUIDE WIRE; BUDDY WIRE
• Outcome Attributed to Adverse Event: Required Intervention