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

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.

• Brand Name: NC TRAVELER CORONARY DILATATION CATHETER
• Type of Device: CORONARY 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 Key: 6214764
• MDR Text Key: 63735400
• Report Number: 2024168-2016-09379
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 1013151-12
• Device Lot Number: 40718G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1