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

Catalog Number	1013469-200
Medical Device Problem Codes	Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Use after damage.Evaluation summary: visual and functional inspection was performed on the returned device.The leak was confirmed.A review of the lot history record identified one associated exception that appears to be related to this complaint.Additionally, a review of the complaint history did not indicate a lot specific issue.It should be noted that the armada 18 otw instruction for use (ifu) states: do not use if the device is damaged.In this case, continuing to use the device did not contribute to the leak.The investigation determined that the reported leak appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the superficial femoral artery with no tortuosity and no calcification.On the second balloon inflation to 4 atmospheres, a leak in the hub of a 5.5 x 200 mm armada 18 percutaneous transluminal angioplasty (pta) balloon catheter was noted.The pta balloon catheter was continued to be used to complete the second inflation at 4 atmospheres following the identification of the leak.No further inflations were performed.The procedure was successfully completed with the deployment of an unspecified stent.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was 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: 7843938
• Report Number: 2024168-2018-06863
• Device Sequence Number: 1129902
• Product Code: LIT
• UDI-Device Identifier: 08717648208355
• UDI-Public: 08717648208355
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/04/2018

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: 02/29/2020
• Device Catalogue Number: 1013469-200
• Device Lot Number: 6092341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 72