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

Catalog Number	1012405-12
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	03/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.The reported patient effect of intimal dissection is listed in the coronary dilatation catheter trek global instructions for use as a known patient effect with use of a coronary dilatation catheter in native coronary arteries.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this event.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.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 the procedure was to treat a 90% stenosed and eccentric lesion in the proximal right coronary artery.A 2.5x12mm trek otw balloon dilatation catheter was being used for pre-dilatation at 12 atmospheres for 6 seconds; however, a dissection occurred.A 2.5x28mm non-abbott stent was deployed at the proximal segment; however, there was continuous contrast expansion in the ascending aorta.A 2.8x16mm rx graftmaster covered stent was deployed at 18 atmospheres and successfully sealed the dissection and extravasation.The patient was hemodynamically stable and asymptomatic.The graftmaster did not cause or contribute to complication.No additional information was provided.

• Brand Name: 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: 7419381
• Report Number: 2024168-2018-02612
• Device Sequence Number: 13470197
• Product Code: LOX
• UDI-Device Identifier: 08717648153976
• UDI-Public: 08717648153976
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• 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): 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 1012405-12
• Device Lot Number: 80108G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 108