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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012450-20
Device Problems Detachment Of Device Component (1104); Leak/Splash (1354); Difficult To Position (1467); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/14/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). The device was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion located in the distal left anterior coronary artery that was mildly tortuous and less than 10% calcified. The nc trek 3. 25 x 20 mm balloon was advanced and prepped inside the patient, however, during preparation, a leak was observed from the balloon. Resistance was felt during advancement to the lesion with the guiding catheter. During removal, resistance was felt and the proximal shaft of the balloon dilatation catheter (bdc) separated. Another balloon catheter was advanced to trap the separated portion in the introducer sheath and the entire system was removed as a single unit. It was confirmed that no separated portion was left in the patient. Another bdc was used to complete the procedure. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: the device was returned for analysis. Visual inspections were performed on the returned device. The shaft separation was confirmed. The difficult to position, leak, and difficult to remove could not be replicated in a testing environment due to the condition of the returned device. The investigation was unable to determine a conclusive cause for the reported difficulties. It should be noted the nc trek rx coronary dilatation catheter instructions for use states: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise complications may occur. 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. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
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Brand NameNC TREK 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 Key6012763
MDR Text Key56919017
Report Number2024168-2016-06791
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Catalogue Number1012450-20
Device Lot Number51130G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/23/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2016
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: 10/07/2016 Patient Sequence Number: 1
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