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

Model Number	A2040-200
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.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 the procedure was performed to treat an 80% stenosed, moderately tortuous, and moderately calcified lesion in the posterior descending artery.A 4.0x200mm armada 14 balloon catheter was prepared per the instructions for use.The balloon catheter was being used for pre-dilatation; however, the balloon only partially inflated and a leak at the hub was noted.The balloon catheter was removed and the procedure was successfully completed with a 4.0x120mm armada 14 balloon catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The complaint information was reviewed and analysis of the returned unit.The inflation problem and leak were confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other complaints.The investigation determined that the reported inflation issue and leak was due to damage noted to the inner member.Although a cause for the damage could not be determined, there was no leak noted during preparation for use indicating that the damage was not pre-existing.Additionally, based on the evaluation of the returned unit and scanning electron microscopy analysis, the inner member damage may be attributed to mechanical damage and may suggest that an object was inserted into the inflation port; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 11298494
• Report Number: 2024168-2021-00996
• Device Sequence Number: 19091353
• Product Code: DQY
• UDI-Device Identifier: 08717648156175
• UDI-Public: 08717648156175
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: A2040-200
• Device Catalogue Number: A2040-200
• Device Lot Number: 0070941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 06/25/2021
• 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: GUIDE WIRE: COMMAND