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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER
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ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012274-15
Device Problems Material Separation (1562); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2020
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Na.
 
Event Description
It was reported that the procedure was performed to treat a de novo lesion in the heavily calcified, moderately tortuous, 90% stenosed proximal right coronary artery.A 3x15mm trek balloon dilatation catheter (bdc) was advanced with slight resistance with the anatomy.After deflation, the shaft separated, so the bdc was removed together with the whole system to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
 
Event Description
It was reported that the procedure was performed to treat a de novo lesion in the heavily calcified, moderately tortuous, 90% stenosed proximal right coronary artery.A 3x15mm trek balloon dilatation catheter (bdc) was advanced with slight resistance with the anatomy.After deflation, the shaft separated, so the bdc was removed together with the whole system to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was received: the balloon of the 3x15mm trek balloon dilatation catheter (bdc) was separated.No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis.The reported shaft material separation and the reported balloon material separation was able to be confirmed.The reported difficult to advance was unable to be replicated in a testing environment as it was based on operational circumstances.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 from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the heavily calcified, moderately tortuous and 90% stenosed anatomy resulting in the reported difficult to advance.During removal, interaction with the heavily calcified, moderately tortuous and 90% stenosed anatomy and/or manipulation of the device resulted in the noted device damages (stretched inner/outer member, stretched/torn guide wire exit notch, bunched balloon, torn inner member, torn balloon) and ultimately resulted in the reported shaft/noted inner member material separation and the reported/noted balloon material separation.The noted multiple bends on the hypotube likely occurred due to handling or during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
 
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Brand Name
TREK CORONARY DILATATION CATHETER
Type of Device
CORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key11028388
MDR Text Key222082475
Report Number2024168-2020-10637
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138430
UDI-Public08717648138430
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,distri
Type of Report Initial,Followup
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2023
Device Model Number1012274-15
Device Catalogue Number1012274-15
Device Lot Number00625G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Date Manufacturer Received01/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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