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

Model Number	B1120-080
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	12/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.It is unknown if the device is returning for analysis.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 a 12x80mm armada 35 percutaneous transluminal angioplasty (pta) catheter was used with a non-abbott guide wire.The pta balloon ruptured, and the catheter became stuck on the guide wire.A portion of the marker and balloon became separated in the anatomy, and surgery was performed to remove the separated portions.There was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
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.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 indication of a lot specific product issue.The armada 35 instruction for use states: do not advance the armada 35 / armada 35 ll pta catheter against significant resistance.The cause of resistance should be determined via fluoroscopy and remedial action taken.In this case, the difficulties appear to be related to case circumstances.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.Device code 2017- failure to follow steps/instructions.
Event or Problem Description
Subsequent to filing the initial mdr, the following information was received: the procedure was performed to treat the common carotid artery.The 12x80mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced without resistance, and the balloon was inflated once to nominal pressure before it ruptured.There was a 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): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9575058
• Report Number: 2024168-2020-00543
• Device Sequence Number: 3042339
• Product Code: LIT
• UDI-Device Identifier: 08717648155000
• UDI-Public: 08717648155000
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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: 02/28/2022
• Device Model Number: B1120-080
• Device Catalogue Number: B1120-080
• Device Lot Number: 80912G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 03/30/2020
• 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: AMPLATZ SUPER STIFF GUIDE WIRE; AMPLATZ SUPER STIFF GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention