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

Catalog Number	1012269-20
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2016
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.Concomitant products: guide wire: runthrough, guide catheter: heartrail jl4 7f.(b)(4).The device was not returned for analysis.It should be noted that the preparation for use section of the mini trek rx coronary dilatation catheter instructions for use states: all air must be removed from the balloon and displaced with contrast prior to inserting into the body; otherwise, complications may occur.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.
Event or Problem Description
It was reported that the procedure was to treat a 100% stenosis located in the mid left anterior descending (lad) artery with moderate tortuosity and heavy calcification.Resistance was felt during advancement of the 1.50 x 20 mm mini trek rx balloon dilatation catheter (bdc) through the lesion for pre-dilatation; however, it was able to cross successfully.The balloon ruptured during the first inflation at 8 atmospheres held for 15 seconds.Upon removal of the ruptured mini trek from the patient's anatomy, a pinhole on the balloon was observed.It was stated that air aspiration of the device was performed inside the patient's anatomy.A replacement nc trek bdc was used to perform the pre-dilatation.The procedure was successfully completed after a xience alpine stent was implanted.There were no adverse patient effects or clinically significant delay in the procedure reported.No additional information was provided.

• Brand Name: MINI 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: 6054848
• Report Number: 2024168-2016-07272
• Device Sequence Number: 13647004
• Product Code: LOX
• UDI-Device Identifier: 08717648138119
• UDI-Public: (01)08717648138119(17)180731(10)50805G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2016

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: 07/31/2018
• Device Catalogue Number: 1012269-20
• Device Lot Number: 50805G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2016
• Initial Report FDA Received Date: 10/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1