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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 Kinked (1339); Leak/Splash (1354); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/10/2018
Event Type  malfunction  
Manufacturer Narrative
Internal file number - (b)(4). Evaluation summary: visual and functional inspections were performed on the returned device. The reported leak was confirmed. The reported difficulty positioning the guide wire and kink were not 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 identified no other similar incidents from this lot. The investigation determined the reported difficulties appear to be related to circumstances of the procedure as return analysis noted that there was a hole puncture in the inner member and the balloon proximal to the distal balloon marker, due to the insertion of the guide wire which subsequently lead to the difficulty positioning the guide wire in the device, the reported leak and the perception of a kink. There is no indication of a product quality issue with respects to the design, manufacturing, or labeling of the device.
 
Manufacturer Narrative
(b)(4). Internal file number -(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 moderately tortuous and moderately calcified left anterior descending artery. During loading of a 2. 0 x 12 mm mini trek balloon catheter onto an unspecified guide wire, prior to the balloon entering the patient, the guide wire would not cross the mid shaft of the balloon. It was noticed that the balloon catheter was kinked. Afterwards, an attempt was made to inflate the balloon and a leak was noted from the distal tip. A new unspecified trek balloon was used to successfully complete the procedure. There was no clinically significant delay in the procedure and no adverse patient effects. 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
MDR Report Key7252722
MDR Text Key286587551
Report Number2024168-2018-00928
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Catalogue Number1012270-12
Device Lot Number71109G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/05/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2018
Is This a Reprocessed and Reused Single-Use Device? No

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