MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	A2020-200
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that during an intervention in the left superficial femoral artery with moderate stenosis, after inflating the armada 14 balloon at the lesion, the balloon completely failed to deflate.A device was used to puncture through the patient's leg and into the balloon to rupture it.Once ruptured, the device was easily removed from the patient.There was no reported adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual, dimensional, and functional inspection was performed on the returned balloon catheter.The reported failure to deflate issue was unable to be confirmed due to the rupture on the balloon and/or the returned 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 other similar incidents and/or complaints reported from this lot.Possible factors that may contribute to deflation failures or slow deflations of the device may include, but not limited to, deflation technique, anatomical conditions/patient anatomical morphology, manufacturing damage, contrast mixing/dilution, bends or kinks of the shaft while inside the anatomy affecting the deflation lumen and/or stretched outer member thereby reducing the inflation/deflation lumen or constricting contrast flow.The investigation was unable to determine a conclusive cause for the reported deflation failure issue.The noted twisted balloon, the balloon folded over itself likely occurred during attempts to retract the balloon catheter during the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12294637
• Report Number: 2024168-2021-06965
• Device Sequence Number: 3210471
• Product Code: DQY
• UDI-Device Identifier: 08717648155994
• UDI-Public: 08717648155994
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: A2020-200
• Device Catalogue Number: A2020-200
• Device Lot Number: 1011941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 09/23/2021
• 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: Required Intervention