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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 1012276-20
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event - estimated.(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that sometime during the week of (b)(6) 2021, the 3.5 x 20 mm trek balloon dilatation catheter (bdc) was advanced into the anatomy and air prepped.Contrast mix was 40/60.The device was then advanced to the heavily calcified lesion for pre-dilatation.The balloon was inflated without issue; however, after inflation, the balloon failed to deflate.Negative was held for up to a couple of minutes, but the balloon did not deflate.Resistance was felt during removal since the balloon remained inflated.There were no adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis.Visual, dimensional and functional inspections were performed on the returned device.The reported deflation issue was confirmed.The reported difficulty removing the device could not 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 of the reported lot did not indicate a lot specific quality issue.In this case, the contrast ratio used was less than the required percentage.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global instructions for use (ifu), specifies that the contrast is 60% contrast medium diluted 1:1 with normal saline.Additionally, it was reported that the device was prepped inside the anatomy.The ifu specifies: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur.In this case, it is unknown if the ifu violations caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.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 Key11467216
MDR Text Key241942519
Report Number2024168-2021-01951
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138584
UDI-Public08717648138584
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,health
Type of Report Initial,Followup
Report Date 04/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2023
Device Model Number1012276-20
Device Catalogue Number1012276-20
Device Lot Number00717G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2021
Date Manufacturer Received03/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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