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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012276-20
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/17/2019
Event Type  Injury  
Manufacturer Narrative
Exemption number e2019001. The balloon remains in the patient. The catheter is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The xience sierra stent referenced is being filed under a separate medwatch report number.
 
Event Description
It was reported that the procedure was to treat a calcified lesion in the tortuous distal right coronary artery (rca). The 3. 50x38 mm xience sierra stent delivery system (sds) was being attempted to be placed distally; however, it could not cross the mid part of the vessel due to calcification. The physician wanted to remove the sds to pre-dilate the distal part of the vessel so the sds was removed. It was not noted that the stent had dislodged until pre-dilatation was being performed with the 3. 50x20 mm trek balloon dilatation catheter (bdc) in the distal vessel and it was seen on angiography. Negative pressure was held for 2 seconds; however, the bdc would not completely deflate and became stuck in the same area as the stent in the calcification. Additionally, the balloon separated from the catheter. Multiple wire attempts were performed to try to remove the stent and balloon but were unsuccessful. Both the stent and balloon remain stuck in calcification in the vessel. No additional information was provided.
 
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Brand NameTREK RX 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 Key9572176
MDR Text Key178346531
Report Number2024168-2020-00528
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,Followup
Report Date 03/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012276-20
Device Catalogue Number1012276-20
Device Lot Number91002G1
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 Received02/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/02/2019
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: 01/09/2020 Patient Sequence Number: 1
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