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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT NC TRAVELER CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1013152-08
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 08/05/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device was initially reported as returning for analysis, but has now been reported as not returning because it was discarded at the account. (b)(4). The device was not returned for evaluation. 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 reported patient effect of intimal dissection is listed in the coronary dilatation catheters, nc traveler rx, instructions for use as a known patient effect. A conclusive cause for the reported patient effect of intimal dissection and the relationship to the product, if any, cannot be determined. The investigation determined the reported physical resistance and additional treatment appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
Subsequent to the previously filed medwatch report, additional information received states that resistance was felt during advancement of the 2. 75 x 08 mm nc traveler rx balloon dilatation catheter (bdc) to the target lesion. The balloon was inflated to 18 atmospheres. Following the use of the bdc, a dissection was observed in the target lesion. An unspecified stent implant was used to successfully treat the dissection. No additional information was provided.
 
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information. The nc traveler device is currently not commercially available in the u. S. ; however, it is similar to a device sold in the u. S.
 
Event Description
It was reported that the procedure was to treat a de novo lesion in the mildly tortuous, moderately calcified, proximal circumflex (cx) coronary artery. During use of the 2. 75 x 08 mm nc traveler rx balloon dilatation catheter, a dissection was observed. No additional information was provided.
 
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Brand NameNC TRAVELER 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 Key7075630
MDR Text Key109564475
Report Number2024168-2017-09322
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Catalogue Number1013152-08
Device Lot Number70309G1
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 Received12/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/01/2017 Patient Sequence Number: 1
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