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

Catalog Number	1013470-040
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2017
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.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right common femoral artery.During the first inflation of the 6mmx40mmx150cm armada 18 balloon dilatation catheter (bdc) to 10 atmospheres, a leak was noted at the distal end of the strain relief tube.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.A new armada 18 bdc was used to successfully complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
Internal file number - (b)(4).Evaluation summary: abbott vascular (av) analyzed the returned device and confirmed the reported leak in the distal end of the hub.A review of the complaint handling database found no similar incidents from this lot.Av reviewed the lot history record and there were no manufacturing nonconformities that would have contributed to this complaint.Av conducted root cause analysis and determined the most probable cause, which appears to be related to manufacturing.The issue is being addressed per internal operating procedures.Av will continue to trend the performance of these devices.

• 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: 6591225
• Report Number: 2024168-2017-04479
• Device Sequence Number: 16344245
• Product Code: LIT
• UDI-Device Identifier: 08717648208393
• UDI-Public: (01)08717648208393(17)200331(10)6100541
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2017

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: 03/31/2020
• Device Catalogue Number: 1013470-040
• Device Lot Number: 6100541
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 77