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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 1013151-12
Device Problems Inflation Problem (1310); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/09/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant medical products: guide wire: runthrough ultra floppy. Guide catheter: 6f taiga ebu3. 5. Stent: resolute integrity 3. 0x30mm. The nc traveler is currently not commercially available in the u. S. However, it is similar to a device sold in the us. 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 located from the proximal to mid left anterior descending (lad) artery with mild tortuosity and moderate calcification that is (b)(4) stenosed. The proximal lad lesion was treated with a non-abbott stent. The 2. 50 x 12 mm nc traveler rx bdc was advanced to the mid lad lesion and crossed successfully; however, the balloon would not inflate past 4 atmospheres of pressure. No significant leak of contrast was observed. Upon removal of the bdc from the anatomy, it was confirmed that the leak was located at the guide wire port. A replacement nc traveler was used and the procedure was successfully completed after a xience alpine stent was implanted. There were no adverse patient effects or clinically significant delay in the procedure reported. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual and functional inspections were performed on the returned device. The reported leak and inflation issue were confirmed. It should be noted that the instruction for use, specifies: 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. The investigation was unable to determine a conclusive cause for the reported leak; however the reported inflation issue appears to be related to operational circumstances due to the leak (noted tear). There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Event Description
Additional information: it was reported that air aspiration was performed inside of the anatomy.
 
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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 Key6214764
MDR Text Key63735400
Report Number2024168-2016-09379
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
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 03/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2017
Device Catalogue Number1013151-12
Device Lot Number40718G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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