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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER Back to Search Results
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). 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.
 
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.
 
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Brand NameTREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY 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 Key6962313
MDR Text Key248191116
Report Number2024168-2017-08333
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Catalogue Number1012274-20
Device Lot Number70717G2
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/02/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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