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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 1012452-12
Device Problem Break (1069)
Patient Problems Air Embolism (1697); Bradycardia (1751)
Event Date 02/07/2017
Event Type  Injury  
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 lesion located in the left anterior descending artery. During pre-dilatation of the lesion, when the 3. 75 x 12 mm nc trek balloon was inflated, a gaseous emboli leak occurred due to a spontaneous shaft break. The leak occurred at low (nominal) pressure causing bradycardia (vagal) which was treated with adrenaline and atropine. The patient was kept in the hospital for an overnight stay for observation. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual inspection was performed on the returned device. The reported shaft separation was confirmed. The reported leak could not be replicated/tested in a testing environment due to the condition of the returned device. The reported patient effects of embolism and bradycardia, which is considered synonymous to arrhythmia, are listed in the coronary dilatation catheters (cdc), nc trek rx, instruction for use are known patient effects. 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 of the reported lot identified no other similar incidents from this lot. The investigation determined the reported complaints and patient effects appears 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 this device.
 
Event Description
Subsequent to the previously filed medwatch report, new information was received as follows: no device issues were noted during preparation of the device prior to use. There was no resistance felt during removal of the protective sheath or during advancement of the catheter to the lesion. The shaft separation observed resulted in air coming from the catheter. There was no issue during removal of the separated shaft from the patient. Another balloon catheter was used to complete the procedure. The final outcome for the patient was good. 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 Key6411829
MDR Text Key70174368
Report Number2024168-2017-02218
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFR
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 05/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Catalogue Number1012452-12
Device Lot Number61102G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/16/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/16/2017 Patient Sequence Number: 1
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