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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT MINI TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012270-12
Device Problems Deflation Problem (1149); Difficult or Delayed Positioning (1157); Inflation Problem (1310); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/08/2019
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 was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat lesions in the left anterior descending (lad) and diagonal coronary arteries. The 2. 00x12 mm mini trek rx balloon dilatation catheter (bdc) was used first in the lad and the bdc worked well with a nice result. The second dilatation was in the diagonal artery and although the balloon could be seen with the markers, the difference between inflation and deflation could not be seen. It was attempted to inflate twice to 8 atmospheres and then negative pressure was held for a few seconds. There was only resistance during removal of the bdc in the sheath at the end. When the bdc was pulled out of the patient, it was still inflated, deflation was not possible. A non-abbott balloon was used to complete the procedure. There were no adverse patient effects and there was no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameMINI 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 Key8382605
MDR Text Key137567816
Report Number2024168-2019-01607
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K103110
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 05/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Catalogue Number1012270-12
Device Lot Number81012G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2018
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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