MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	1013468-060
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.A visual and functional inspection was performed on the returned device.The leak was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The investigation determined the reported leak appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Av will continue to trend the performance of these devices.
Event or Problem Description
It was reported that the armada 18 was inflated to 8 atmospheres at the heavily calcified, left ostial superficial femoral artery, but the pressure in the indeflator was slowly losing pressure.Contrast was noted leaking from the hub of the armada 18, but the lesion was successfully treated at nominal pressure for thirty seconds to one minute.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.

• Brand Name: ARMADA 18 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7661267
• Report Number: 2024168-2018-05148
• Device Sequence Number: 11039948
• Product Code: LIT
• UDI-Device Identifier: 08717648208188
• UDI-Public: 08717648208188
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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: 10/31/2019
• Device Catalogue Number: 1013468-060
• Device Lot Number: 6051841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 88