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

Catalog Number	1012402-15A
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	05/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of intimal dissection is listed in the coronary dilatation catheters (cdc), mini trek instructions for use as a known patient effect.A conclusive cause for the reported patient effect and the relationship to the product, if any, could not 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 during a procedure of the heavily calcified, tight, long circumflex artery (cx), several attempts with multiple size dilatation catheters failed, because the devices could not get to the lesion.A guideliner was used with the 1.5 x 15 mm minitrek balloon dilatation catheter and after inflation a long dissection was noted in the cx and obtuse marginal arteries.Fractional flow reserve (ffr) and surgical consultation determined that the patient would be treated with vessel bypass.The patient was transferred for surgical intervention.No additional information was provided.

• Brand Name: MINI TREK II OTW 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: 7512636
• Report Number: 2024168-2018-03564
• Device Sequence Number: 13801886
• Product Code: LOX
• UDI-Device Identifier: 08717648180835
• UDI-Public: 08717648180835
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/14/2018

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: 03/31/2019
• Device Catalogue Number: 1012402-15A
• Device Lot Number: 60401G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/14/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 64