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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 1012451-08
Device Problems Detachment Of Device Component (1104); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/08/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Visual inspection was performed on the returned device. The reported separation was confirmed. The reported balloon rupture could not be confirmed due to the condition of the returned device. It was reported that the balloon ruptured at 22 atmopsheres, which is above the rated burst pressure. It should be noted that the nc trek rx coronary dilatation catheters instructions for use states: balloon pressure should not exceed the rated burst pressure. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. 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 balloon rupture; however, the reported balloon separation appears to be related to circumstances of the procedure. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (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 relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion in the left anterior descending artery. A 3. 5 x 8 mm nc trek balloon dilatation catheter was being used for post-dilatation; however, the balloon ruptured during first inflation at 22 atmospheres. The balloon ruptured in a way that it separated and half of the balloon is lost in the patient. The guiding catheter was flushed; however, the missing balloon piece was not there. The case was concluded and the patient was monitored overnight; however, has since been discharged home. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
 
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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 Key6669946
MDR Text Key108174067
Report Number2024168-2017-05391
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Catalogue Number1012451-08
Device Lot Number70313G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2017
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: 06/27/2017 Patient Sequence Number: 1
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