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

Model Number	B2120-040
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
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 during device preparation and before use, the protective sheath of the armada 35 could not be removed and the proximal shaft broke.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned balloon catheter.The reported difficulty to remove the protective sheath was unable to be confirmed since the protective sheath was not returned on the balloon.The reported proximal shaft separation was not confirmed as there were no separations noted on the device.There was no damage observed to 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 incidents and/or complaints reported from this lot.Factors that may contribute to difficulty removing the protective sheath may include, but not limited to, normal variation within the manufacturing process, protective sheath removal technique, damage during manufacturing, damage to the protective sheath, an undersized sheath and/or an oversized balloon profile, mishandling or positive pressure applied during preparation.Design and manufacturing controls have been established to mitigate possible causes.The investigation was unable to determine a conclusive cause for the reported difficulty to remove the protective sheath and proximal shaft separation.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 12145415
• Report Number: 2024168-2021-05893
• Device Sequence Number: 14506894
• Product Code: LIT
• UDI-Device Identifier: 08717648155550
• UDI-Public: 08717648155550
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: 02/28/2023
• Device Model Number: B2120-040
• Device Catalogue Number: B2120-040
• Device Lot Number: 90918G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1