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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT MINI TREK II OTW CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012401-12A
Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Deformation Due to Compressive Stress (2889)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/12/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The other 1. 20x12mm mini trek referenced is filed under a separate medwatch report number. Visual and functional inspections were performed on the returned device. The reported loose connection and leak could not be confirmed. The reported kink was confirmed. 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 did not indicate a lot specific quality issue. The investigation was unable to determine a conclusive cause for the reported loose connection and leak; however, the reported kink appears to be related to operation context. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that during the procedure to treat an unspecified lesion, there was a poor connection between the luer lock syringe and a 1. 20x12mm mini trek balloon dilatation catheter. The connection was leaking while attempting to inject saline/contrast in the catheter lumen. A new unspecified bdc was used to successfully complete the procedure. No additional information was provided. An additional 1. 20x12mm mini trek bdc was received with the inner and outer members kinked proximal to the proximal seal. No other damage was noted to the additional balloon catheter. The account confirmed the kink as well as an issue with the connection leaking while attempting to inject saline/contrast in the catheter lumen. The device was used in the same procedure as the complaint mini trek. No additional information was provided.
 
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Brand NameMINI TREK II OTW 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 Key8794478
MDR Text Key151172772
Report Number2024168-2019-05541
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeDA
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
Report Date 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Catalogue Number1012401-12A
Device Lot Number81112G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2018
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: 07/16/2019 Patient Sequence Number: 1
Treatment
OTHER: LUER LOCK SYRINGE
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