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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 Remove (1528); Folded (2630)
Patient Problem Angina (1710)
Event Date 11/06/2014
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Correction: the device was initially reported as returning, but has now been reported as not returning because it was discarded at the account.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.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.Angina is listed in the instructions for use (ifu), in the adverse effects section as a known adverse event.Although a conclusive cause for the reported patient effect and the relationship to the device, if any, cannot be determined, there is no indication of a product quality deficiency with respect to manufacture, design, or labeling.Based on the information reviewed, manufacturing records and similar incident analysis, there is no indication of a product quality deficiency.
 
Event Description
It was reported that the procedure was to treat a lesion in the proximal right coronary artery with heavy tortuosity and moderate calcification.The 5.0 x 12 mm nc trek balloon catheter was un-packaged for use.Resistance was noted during removal of the protective sheath.The nc trek was advanced without issue to the lesion and inflated two times to 14 atmospheres (atm) and 18 atm; however, it was observed that the balloon was unable to be refolded after inflation.During removal, resistance was noted with the anatomy; therefore, the physician withdrew the balloon with the guide wire, as a signal unit.The patient felt chest pain during removal of the trek, but no medication or treatment was needed.The final outcome was satisfactory and the procedure was completed successfully.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
 
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Brand Name
NC 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 Key4287496
MDR Text Key12664037
Report Number2024168-2014-07829
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/06/2014
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 Date01/31/2017
Device Catalogue Number1012455-12
Device Lot NumberBA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/05/2014
Initial Date FDA Received12/01/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/12/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age56 YR
Patient Weight71
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