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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012449-15
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problems Bradycardia (1751); Non specific EKG/ECG Changes (1817); Tissue Damage (2104)
Event Date 04/06/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Evaluation summary: visual,dimensional and functional inspections were performed on the returned device. The reported deflation issues could not be confirmed. The reported difficulty removing the device from the vessel could not be replicated in a testing environment as it is based on operational circumstances. It should be noted that the coronary dilatation catheters, nc trek rx, instruction for use states: if resistance is felt, determine the cause before proceeding. Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and/or damage/separation of the catheter. 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 incidents reported from this lot. The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing and patient effects appear to be related to operational context. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the 3. 0 x 15 mm nc trek rx balloon dilatation catheter (bdc) was being used for post-dilatation of an unspecified stent in the mid right coronary artery (rca). The device was prepped prior to use with no reported issue. The bdc was inflated once to 14 atmospheres. After inflation, the balloon would not completely deflate when negative pressure was held for 40-50 seconds. During this time the patient experienced st segment elevation. The indeflator was exchanged for a new one and held pressure for less than 5 seconds, but the balloon still could not be deflated. The patient experienced the third degree atrioventricular conduct block. About a minute later, all devices were removed with force into the coronary ostium. About 10 minutes later all devices were removed from the patient and there was no more st segment elevation. An additional stent was placed in the ostium to mid rca as a precautionary measure due to potential tissue damage from removing the nc trek balloon so forcefully. A new non-abbott bdc was used to complete the procedure. The final patient outcome was satisfactory. No additional information was provided.
 
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Brand NameNC 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 Key6529685
MDR Text Key113782554
Report Number2024168-2017-03735
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Catalogue Number1012449-15
Device Lot Number70102G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2017
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: 04/28/2017 Patient Sequence Number: 1
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