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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 1012272-15
Device Problems Difficult to Remove (1528); Folded (2630); Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/05/2014
Event Type  malfunction  
Event Description
It was reported that the patient presented with a st elevated myocardial infarction (stemi) and an occluded distal right coronary artery (rca).A prowaterflex guide wire crossed the distal rca lesion.A 2.5x15mm trek dilatation catheter was advanced to the lesion without resistance.Once at the lesion, the markers did not appear aligned co-axially aligned with the wire.After balloon inflation, the balloon locked with the wire and appeared deformed.The balloon was able to deflate, however it remained stuck and intertwined with the wire.Both were removed a single unit and the procedure was completed using another wire and balloon.There were no adverse patient effects and there was no clinically significant delay.The patient is in reported fine condition.There was no additional information provided.
 
Manufacturer Narrative
(b)(4).The device was returned for evaluation.The reported difficult to remove from the guide wire and unusual appearance was confirmed.The reported mis-aligned balloon markers were not confirmed due to the condition of the returned device.Based on visual, dimensional and analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.The prowaterflex guide wire, referenced is being filed under a separate medwatch mfr number.
 
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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 462
Manufacturer (Section G)
EL COYOL, COSTA RICA REG# 3009031392
abbott vascular
26531 ynez road
temecula CA 92591 462
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key4217603
MDR Text Key5078271
Report Number2024168-2014-07141
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 Health Professional,Company Representative
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial
Report Date 10/06/2014
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 Date06/30/2017
Device Catalogue Number1012272-15
Device Lot Number40731G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/06/2014
Initial Date FDA Received10/31/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDE WIRE: PROWATERFLEX
Patient Age65 YR
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