MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 OTW; PERIPHERAL DILATATION CATHETER

Model Number	1013468-200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.It may be possible that the balloon interacted with anatomy or associated devices causing damage to the outer surface and resulting in balloon rupture; however, this could not be determined.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 of the reported lot revealed no other similar incidents.The investigation was unable to determine a cause for the reported balloon rupture.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a calcified lesion in the superficial femoral artery/popliteal artery.The 5.0x200mm armada 18 balloon ruptured during the first inflation at 8 atmospheres.The procedure was successfully completed with an unspecified shorter length balloon dilatation catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA 18 OTW
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9982950
• Report Number: 2024168-2020-03787
• Device Sequence Number: 11747301
• Product Code: LIT
• UDI-Device Identifier: 08717648208249
• UDI-Public: 08717648208249
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2020

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: 04/30/2023
• Device Model Number: 1013468-200
• Device Catalogue Number: 1013468-200
• Device Lot Number: 9112041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR