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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012455-12
Device Problems Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/11/2016
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 is expected to be returned for evaluation. Investigation is not yet complete. It has not yet been received. A follow-up report will be submitted with all additional relevant information. The versaturn guide wire referenced is filed under a separate medwatch manufacturer report reference number.
 
Event Description
It was reported that the procedure was to treat a heavily restenosed non-abbott stent located in the heavily calcified proximal left circumflex (cx) artery. The lesion was a chronic total occlusion (cto). Additionally, there was a lesion located in the proximal left anterior descending artery; therefore, both vessels were wired. One xience alpine stent was deployed in the ostium of the cx. Another xience alpine stent was deployed in the proximal lad to the left main (bifurcation trousers technique). After deployment of the second xience alpine stent, it was observed that upon removal of the versaturn guide wire, the guide wire was broken, but not in two pieces, and was able to be removed from the patient without issue. The nc trek balloon catheter was advanced for post-dilatation of the overlapping stents. After negative pressure was applied, fully deflating the balloon, during retraction of the balloon catheter, the balloon appeared to be stuck on the other unspecified guide wire and could not be advanced or retrieved. The decision was made to remove the remaining guide wire and the balloon catheter together as a single unit. The lesion was rewired to continue the procedure using a new balloon catheter. No adverse patient effects were reported. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: (b)(4). Visual, dimensional and functional inspections were performed on the returned device. The reported resistance felt with difficulty to remove and difficulty to position issues could not be confirmed. 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 similar incidents from this lot. 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 was unable to determine a conclusive cause for the reported difficulties. The additional versaturn guide wire, referenced is filed under a separate medwatch manufacturer report number.
 
Event Description
Returned device analysis confirmed that the guide wire returned inside the nc trek balloon catheter was a versaturn guide wire. No additional information was provided.
 
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Brand NameNC TREK 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 Key5698121
MDR Text Key46621054
Report Number2024168-2016-03575
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Catalogue Number1012455-12
Device Lot Number50817G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2015
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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