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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR RX TREK CORONARY DILATATION CATHETER

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ABBOTT VASCULAR RX TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012280-15
Device Problems Deflation Problem (1149); Off-Label Use (1494); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/08/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the pulmonary artery. The 5. 0x15mm trek balloon dilatation catheter was pressurized twice to 6 atmospheres. The first inflation was completed without issue. On the second inflation, the balloon failed to deflate. Negative pressure was held for several minutes as the balloon never deflated with multiple aspiration attempts to deflate the balloon. There was a delay of 30 minutes due to additional images required during the attempts made to remove the device. The balloon was finally removed fully inflated using force and the guiding catheter. Although a clinically significant delay was reported, there were no reported adverse patient effects due to our device. No additional information was provided.
 
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Brand NameRX TREK
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 Key10733574
MDR Text Key213006797
Report Number2024168-2020-08891
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,Followup
Report Date 12/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012280-15
Device Catalogue Number1012280-15
Device Lot Number00402G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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