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

Model Number	B1040-100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
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
During the device preparation of a 4 x 100mm armada 35, it was noted that more air bubbles were observed than usual during air aspiration.The physician stopped using the device suspecting the possibility of a leak.The armada 35 was not used and there was no patient involvement.Another armada 35 was used to successfully complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device and the reported leak was unable to be confirmed as the device was able to inflate and hold pressure without any leaks noted.Additionally, it was not guaranteed that the correct device had returned.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.Possible factors that may contribute to leaks during preparation may include, but are not limited to, manufacturing, damage to the balloon, damage to the inflation lumen, incorrect prep, damaged to inflation device, hub cracks, or loose connections.The investigation was unable to determine a conclusive cause for the reported balloon leak during prep.It is possible that the connection between the inflation device and hub was not securely connected resulting in the reported leak or bubbled during preparation; however, this could not be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• 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: 11067440
• Report Number: 2024168-2020-10915
• Device Sequence Number: 2651900
• Product Code: LIT
• UDI-Device Identifier: 08717648154546
• UDI-Public: 08717648154546
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/03/2021

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: 07/31/2022
• Device Model Number: B1040-100
• Device Catalogue Number: B1040-100
• Device Lot Number: 90218G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1