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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 1012272-30
Device Problems Inflation Problem (1310); Material Rupture (1546)
Patient Problem Insufficient Information (4580)
Event Date 02/17/2021
Event Type  malfunction  
Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported inflation issue was confirmed.Additionally, an attempt was made to pressurize the balloon to rated burst pressure (rbp) of 14 atmospheres, and a leak was observed coming from a balloon pinhole located distal to the balloon proximal marker band, confirming the reported inflation issue 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 and/or complaints from this lot.There was no leak noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely that the balloon interacted with the heavily calcified anatomy such that the balloon became damaged, ruptured, and subsequently resulted in the reported inflation issue.The investigation determined the reported inflation issue and noted balloon rupture appear 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.
 
Event Description
It was reported that the procedure was performed to treat a target lesion in the heavily calcified circumflex (cx) artery.A non-abbott rotational athetectomy device was used, then the 2.5 x 30 mm trek dilatation catheter was advanced to the target lesion.The trek dilatation catheter balloon was inflated to 13 atmospheres (atm), then would not inflate any more.There was no leak noted and no balloon rupture was suspected, as there was no bleed back noted.The balloon seemed to be fully inflated and the balloon deflated without issue.The device was removed without difficulty and there was no adverse patient effect.Additional rotational atherectomy was performed, and an nc trek was then used without issue.There was no adverse patient effect and no clinically significant delay reported.Returned device analysis indicates that a leak was observed in the dilatation catheter balloon.Additional follow up with the site indicated that no leak was noted by the physician.No additional information was provided.
 
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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
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS  
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key11611462
MDR Text Key245383701
Report Number2024168-2021-02701
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138324
UDI-Public08717648138324
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 Physician
Type of Report Initial
Report Date 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2022
Device Model Number1012272-30
Device Catalogue Number1012272-30
Device Lot Number91010G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/12/2021
Initial Date FDA Received04/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age76 YR
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