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

Catalog Number 1012274-20

Device Problems Deflation Problem (1149); Kinked (1339); Difficult to Remove (1528); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a heavily calcified mid left anterior descending artery that did not have any tortuosity.A 3.0 x 20 mm trek balloon catheter was used and did not meet any resistance during advancement.The balloon was inflated once at 8 atmospheres; however, the balloon failed to deflate.There was a failed attempt to pull negative pressure to deflate the balloon, and there was also an unsuccessful attempt to use a syringe and pull a double negative.Therefore, the device had to be forcefully pulled out from the anatomy.Additionally, a kink at the tip of the device occurred when the device was removed, and the proximal seal of the balloon was also stretched.Further dilatation was then done with an unspecified balloon dilatation catheter, two unspecified trek balloon catheters, and an unspecified xience stent was implanted in the lesion to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual, dimensional and functional inspections were performed on the returned device.The reported stretching was confirmed; however, the reported kink was not confirmed.The reported deflation issue could not be replicated in a testing environment due to the condition of the returned device.The reported difficulty to remove complaint could not be replicated in a testing environment as it is based on operational circumstances.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 from this lot.It should be noted coronary dilatation catheters (cdc), trek rx instruction for use states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and/or damage/separation of the catheter.The investigation was unable to determine a conclusive cause for the reported deflation issue or the kink; however, the reported stretching of the outer member at the proximal seal and the difficulty removing the bdc appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: 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: 6962313
• MDR Text Key: 90659620
• Report Number: 2024168-2017-08333
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 1012274-20
• Device Lot Number: 70717G2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• 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
• Patient Age: 78 YR