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

Catalog Number	1013465-040
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/04/2017
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.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 determined the most probable root cause is variability in the gluing process during manufacturing.The issue will be addressed per internal operating procedures.Av will continue to trend the performance of these devices.
Event or Problem Description
It was reported that during preparation of the 3.0 x 40 mm armada 18 dilatation catheter, air was pulled back into the syringe and it was thought that there was a leak at the hub.The device was not used in the patient anatomy and there was no adverse patient effect.A second armada 18 was used without issue.There was no adverse patient effect and no clinically significant delay.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: 6553055
• Report Number: 2024168-2017-04009
• Device Sequence Number: 802963
• Product Code: LIT
• UDI-Device Identifier: 08717648207860
• UDI-Public: (01)08717648207860(17)200131(10)6082641
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 05/08/2017

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: 01/31/2020
• Device Catalogue Number: 1013465-040
• Device Lot Number: 6082641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2017
• Initial Report FDA Received Date: 05/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1