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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 Inflation Problem (1310); Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/21/2018
Event Type  malfunction  
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 returned for analysis, visual and functional inspections were performed. The reported loose or intermittent connection was not confirmed. A crack was noted on the hub of the device, when attempting to inflate the balloon the balloon did not inflate as fluid leaked from the noted cracks on hub. In this case, it is possible that the inflation device was over torqued during attempts to connect to the hub of the device, resulting in the noted crack and subsequently the reported loose or intermittent connection. 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 difficulty appears to be related to operational context. There is no indication of a product quality issue with respects to the design, manufacturing, or labeling of the device.
 
Event Description
It was reported the procedure was to treat a lesion in the left anterior descending coronary artery. The 2. 50x20 mm trek rx balloon dilatation catheter (bdc) was advanced without issue in the patient anatomy, however when attempting to connect the indeflator to the hub of the trek, the hub of the trek would not connect to the indeflator. Another indeflator was attempted to be connected, but it also did not connect to the hub. The bdc was replaced with a new same size trek and it was able to connect with the same indeflator without issue this time. There were no adverse patient effects and no clinically significant delay in the procedure. Returned device analysis revealed the hub was cracked, and the balloon failed to inflate; a leak was noted coming from the crack on the hub. No additional information was provided.
 
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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 Key7347111
MDR Text Key103157941
Report Number2024168-2018-01897
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
Report Date 03/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue Number1012272-20
Device Lot Number71006G2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2017
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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