MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	B2050-060
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2017
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.The device was returned for analysis and abbott vascular (av) confirmed the reported difficulty in deflating the balloon.A review of the complaint handling database found no similar incidents from this lot.Av conducted a thorough root cause analysis and determined the deflation issue is potentially related to manufacturing.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 patient underwent a peripheral procedure, treating a target lesion in the right iliac artery.The armada 35 dilatation catheter was advanced to the target lesion and was inflated 1 time, to 18 atmospheres (atm) and deflated without issue.The device was inflated a second time, to 18 atm, but deflated slowly.Difficulty was noted removing the device, and upon removal, the balloon was noted to have bunched up towards the tip of the device.A second unspecified dilatation catheter was used, and was followed by stenting.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

• Brand Name: ARMADA 35 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: 7216017
• Report Number: 2024168-2018-00557
• Device Sequence Number: 738647
• Product Code: LIT
• UDI-Device Identifier: 08717648155185
• UDI-Public: 08717648155185
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• 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): 01/24/2018

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: 08/31/2019
• Device Catalogue Number: B2050-060
• Device Lot Number: 60331G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 73