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

Catalog Number	B2060-060
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2017
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.Evaluation summary: the device was returned for analysis and abbott vascular (av) confirmed the reported crack in the hub and subsequent leak when the device was pressurized.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.Av conducted root cause analysis and determined the issue may be related to a potential product quality issue.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 procedure was to treat a lesion in the superficial femoral artery.The 6mmx60mmx135cm armada 35 balloon dilatation catheter (bdc) was advanced in the patient anatomy however, during inflation of the balloon a leak was noted coming from a crack on the hub of the armada 35 balloon bdc.A new bdc was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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: 7204093
• Report Number: 2024168-2018-00462
• Device Sequence Number: 1447999
• Product Code: LIT
• UDI-Device Identifier: 08717648155277
• UDI-Public: 08717648155277
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/18/2018

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: B2060-060
• Device Lot Number: 61003G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2017
• Initial Report FDA Received Date: 01/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 77