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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER

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AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012276-25
Device Problems Detachment Of Device Component (1104); Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/30/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. Continued: a snare device was then used to retrieve the balloon from the anatomy. Another balloon was used to successfully complete the procedure. The patient remained stable during and after the procedure. There was no adverse patient sequela reported. No additional information was provided. The wiggle guide wire referenced is being filed under a separate medwatch report number. Evaluation summary: visual and functional inspections were performed on the returned device. The reported separation was confirmed. The reported difficulty removing the device could not be replicated in a testing environment as it was based on operational circumstances. The reported deflation issue could not be replicated in a testing environment due to the condition of the returned device. 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 from this lot. The investigation was unable to determine a conclusive cause for the reported deflation issue. 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 to treat a heavily calcified right coronary artery (rca). During unpacking of the first trek balloon dilatation catheter (bdc) , it was noted that there was a kink in the dispenser hoop coil. When the device was removed, it was noted that the proximal shaft was kinked/bent. Another balloon was used to continue the procedure. However, the physician deemed it necessary to upsize on the bdc. Another trek bdc was used and advanced to the lesion with no resistance. It was inflated once at nominal pressure. During deflating, it was noted that the balloon would not deflate at all. The indeflator was then removed and a syringe was used to pull negative for 20 seconds multiple times. Blood was present in the syringe. It was thought that the balloon had ruptured. However, through a second check, the balloon was still fully inflated. The physician then decided to remove the balloon (fully inflated), when the distal shaft broke off and the balloon remained in the rca. Resistance was felt with the hi-torque wiggle guide wire (gw) during the removal of the bdc when the shaft broke. Two non-abbott gw were then used in an attempt to poke and rupture the balloon, but was unsuccessful. A second attempt was made with another non-abbott gw and a microcatheter, but was unsuccessful. Then another unspecified gw was used in an attempt to deflate the balloon, with a bovi-wire (electrical current) technique, and the balloon was successfully ruptured/deflated.
 
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Brand NameTREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
EL COYOL, COSTA RICA REG# 3009031392
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key7621907
MDR Text Key111766024
Report Number2024168-2018-04706
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 Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Catalogue Number1012276-25
Device Lot Number60624G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
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: 06/20/2018 Patient Sequence Number: 1
Treatment
GUIDE WIRE: WIGGLE WIRE SHEATH: 6FR
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