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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 1012272-20
Device Problems Detachment Of Device Component (1104); Crack (1135); Inflation Problem (1310); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2016
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 relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion located in the moderately tortuous, heavily calcified right coronary artery. The 2. 5 x 20 mm trek balloon was advanced to be used for predilatation; however, the balloon would not inflate. Contrast was seen coming into the guiding catheter and it was observed that there was a crack midway in the shaft of the balloon catheter. After retraction of the device from the patient the area where the crack was observed became separated into two pieces. There were no device issues noted during preparation of the device. A new same size, same type balloon catheter was used successfully for the case. No adverse patient effects or clinically significant delay in the procedure were reported. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual inspection was performed on the returned device. The reported separation was confirmed. The reported break, inflation issue and leak could not be replicated in a testing environment due to the condition of the returned device. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no other incidents from this lot. The investigation determined the reported difficulties appear 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 the device.
 
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Brand NameTREK 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 Key6187787
MDR Text Key63135309
Report Number2024168-2016-09024
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 company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Catalogue Number1012272-20
Device Lot Number61005G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/15/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2016
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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