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

Catalog Number 1012268-06

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2016

Event Type  malfunction  

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 analysis.It should be noted that the preparation for use section of the mini trek rx coronary dilatation catheter instructions for use specifies: all air must be removed from the balloon and displaced with contrast prior to inserting into the body; otherwise, complications may occur.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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.

Event Description

It was reported that the procedure was performed to treat a 99% stenosed lesion in the mid left anterior descending artery, with mild tortuosity and heavy calcification.The 1.2 x 6 mm mini trek balloon catheter prepared for use in the anatomy.The mini trek was advanced, but resistance was noted with the calcification, and the mini trek could not cross the lesion.The balloon was inflated, but ruptured at 10 atmospheres (atm).The balloon catheter was removed and the lesion was successfully dilated with a new 1.2 x 6 mm mini trek.An additional 2.5 x 12 mm trek balloon was used for further dilatation.Rotoblation was performed, and a 3.0 x 48 mm xience xpedition was used to successfully treat the lesion with a good result.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the initial report, the following information was provided: the 1.2 x 6 mm mini trek balloon catheter was advanced to the lesion, but ruptured upon inflation.No additional information was provided.

• Brand Name: MINI TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6186713
• MDR Text Key: 63085004
• Report Number: 2024168-2016-09012
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138027
• UDI-Public: (01)08717648138027(17)181031(10)51120G1
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 1012268-06
• Device Lot Number: 51120G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: PROGRESS 140T
• Patient Age: 70 YR
• Patient Weight: 100