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

Model Number	B1080-060
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Perforation of Vessels (2135)
Date of Event	07/16/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.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 and/or complaints reported from this lot.The reported patient effects of perforation and death are listed in armada 35 / armada 35 ll, instructions for use as known patient effect(s) of coronary stenting procedures.It should be noted that the armada 35 / armada 35 ll instructions for use (ifu) states: the diameter of the expanded balloon should not exceed that of the artery just distal, or proximal, to the stenosis.Verify that the selected accessories accommodate the balloon catheter as labeled.The investigation determined the reported incorrect device selection causing perforation of the vessel, cardiac arrest, unexpected medical intervention/additional therapy non-surgical treatment ultimately resulting in the death of the patient and appear to be a result of user error.It should be noted that the physician was aware he used a balloon too large for the vessel.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported the procedure was to treat a lesion in the external iliac artery.The 8.0x60mm armada 35 balloon dilatation catheter (bdc) was selected even though the balloon was oversized for the vessel.The balloon was inflated and the vessel perforated.The patient went into cardiac arrest and resuscitation was attempted however was unsuccessful and the patient died.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: 12246693
• Report Number: 2024168-2021-06644
• Device Sequence Number: 19926211
• Product Code: LIT
• UDI-Device Identifier: 08717648154874
• UDI-Public: 08717648154874
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: B1080-060
• Device Catalogue Number: B1080-060
• Device Lot Number: 91123G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 07/29/2021
• 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: Death