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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 1012278-15
Device Problems Material Separation (1562); Failure to Deflate (4060)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2021
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation. 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. The investigation was unable to determine a conclusive cause for the reported failure to deflate. However, factors that may contribute to difficulty deflating the balloon may include, but are not limited to, deflation technique, contrast concentration, tortuous anatomy, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen. The reported separation, additional treatment and removal of foreign body appear to be related to circumstances of the procedure as the shaft separated since the balloon remained inflated during attempts to remove the device. Additional treatment was performed in an attempt to retrieve the balloon via lasso, the balloon was intentionally crushed with the lasso and thus partially deflated and ultimately retrieved through the left radial artery. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was to treat a left anterior descending artery (lad) with a kissing technique. A 2. 5x23mm xience stent was in the diagonal artery and a 4x15mm trek balloon was in the lad. There was no resistance when advancing both devices in the non-abbott guiding catheter. The stent was implanted without issue and the stent delivery system was removed. The trek balloon was inflated once at nominal pressure without issue. However, after the kissing technique was used, the trek balloon completely failed to deflate. The balloon remained inflated at the distal part of the guiding catheter and when pulling it in the shaft separated. In an attempt to retrieve the balloon via lasso, the balloon was intentionally crushed with the lasso and thus partially deflated and ultimately retrieved through the left radial artery. There were no adverse patient effects and no clinically significant delay. No additional information was provided.
 
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Brand NameTREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY 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 Key12512542
MDR Text Key272682819
Report Number2024168-2021-08434
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012278-15
Device Catalogue Number1012278-15
Device Lot Number91129G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2019
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: 09/22/2021 Patient Sequence Number: 1
Treatment
7F SHEATH; EBU 3.5 6F MEDTRONIC GUIDING CATHETER; XIENCE 2.5X23MM
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