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

Catalog Number	1013466-150
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/08/2017
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.Date of event is estimated.Evaluation summary: visual and functional inspections were performed on the returned device.The reported leak was confirmed due to a crack in the sidearm.It is likely that syringe or flushing device was over-tightened causing the sidearm to crack at the threads.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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 during preparation of the 4.0x150 armada 18 balloon catheter, a leak was noted in the balloon.The device was set aside and a new balloon catheter was used to complete the procedure.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.
Additional Manufacturer Narrative
Internal file number - 334904/1-1.

• 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: 7067186
• Report Number: 2024168-2017-09222
• Device Sequence Number: 13768076
• Product Code: LIT
• UDI-Device Identifier: 08717648208003
• UDI-Public: 08717648208003
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/29/2017

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: 07/31/2020
• Device Catalogue Number: 1013466-150
• Device Lot Number: 7021041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/15/2017
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1