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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 1012405-20
Device Problems Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/25/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Evaluation summary: visual, dimensional and functional inspections were performed on the returned device. The reported difficulties were confirmed. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no other incidents from this lot. The investigation was unable to determine a conclusive cause for the reported difficulties. 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 two additional devices referenced are filed under separate medwatch reports.
 
Event Description
It was reported that during the procedure to treat a target lesion in the 1st obtuse marginal artery, the balance guide wire was advanced to the target lesion without difficulty. The 2. 5 x 20 mm trek dilatation catheter was advanced over the guide wire; however, it was noted to have difficulty during advancement due to resistance with the guide wire. It was noted that the dilatation catheter was sticking with the guide wire. The dilatation catheter was removed with difficulty due to resistance with the guide wire. The guide wire was re-wet and a 2. 5 x 15 mm xience alpine stent delivery system was advanced; however, this device also experienced difficulty advancing over the balance guide wire and felt that it was sticking. The stent delivery system was removed with resistance due to the guide wire. The procedure continued using non-abbott devices. There was no adverse patient effect and no clinically significant delay. 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 Key5579093
MDR Text Key43163485
Report Number2024168-2016-02426
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
Report Date 04/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Catalogue Number1012405-20
Device Lot Number50930G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2015
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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