MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

Catalog Number	1012443-20
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2018
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.(b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.The nc trek otw coronary dilatation catheters information for use states that the device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis.The investigation was unable to determine a conclusive cause for the reported complaint.There is no indication of a product quality issue with respects to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the patient underwent a procedure to treat a target lesion in the iliac artery.The 5.0 x 20 mm nc trek dilatation catheter was advanced to the target lesion and inflated.During the first inflation, the nc trek balloon ruptured at an unspecified pressure.The device was removed without difficulty and all portions of the balloon dilatation catheter were removed.There was no reported adverse patient effect or a clinically significant delay in procedure.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7207971
• Report Number: 2024168-2018-00489
• Device Sequence Number: 13749546
• Product Code: LOX
• UDI-Device Identifier: 08717648151569
• UDI-Public: 08717648151569
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113464
• 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): 01/19/2018

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 Catalogue Number: 1012443-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR