• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012276-30
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Syncope (1610); Perforation (2001)
Event Date 05/29/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). The product was not returned to abbott vascular for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot or relabeled lot that would have contributed to this event. Additionally, a review of the complaint history identified no other incidents reported from this lot. Based on the reported information, the trek balloon dilatation catheter was inflated once at 16 atmospheres (above rbp), and a perforation was noted after its use. It should be noted that the ifu, cdc, trek rx and mini trek rx, global, instructions for use states: balloon pressure should not exceed the rated burst pressure (rbp). The investigation determined the reported difficulties appear to be related to user error. It is likely that during the inflation of the balloon above rbp, the balloon likely damaged the vessel. A conclusive cause for the reported patient effect of syncope and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the 100% stenosed mid right coronary artery. A 3. 5x30mm trek balloon dilatation catheter was inflated once at 16 atmospheres, and a perforation was noted after its use. Four non-abbott covered stents were used as treatment, and the patient was discharged on (b)(6)2020. The patient returned on (b)(6) 2020 with syncope, but there was no treatment. The patient was discharged on (b)(6) 2020 and the patient is in good condition. There was a clinically significant delay in the procedure. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTREK RX
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 Key10159815
MDR Text Key195310489
Report Number2024168-2020-05081
Device Sequence Number1
Product Code LOX
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
Type of Report Initial
Report Date 06/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012276-30
Device Catalogue Number1012276-30
Device Lot Number91029G1
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 Received05/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/29/2019
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: 06/16/2020 Patient Sequence Number: 1
-
-