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

Catalog Number 1013158-08

Device Problems Deflation Problem (1149); Kinked (1339); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2017

Event Type  Injury  

Manufacturer Narrative

The patient and device codes in f10 were coded by the manufacturer.Patient codes: 2199 labeled na device codes: 1149 not labeled 1339 not labeled 1528 labeled internal file number - 334146/1-1: during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The nc traveler device is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that the procedure was to treat a lesion located in the proximal right coronary artery (rca) that was mildly tortuous and moderately calcified.A stent was deployed in the proximal rca.The nc traveler 4.5 x 8 mm balloon dilatation catheter was advanced to the lesion without any resistance and the deployed stent was post-dilated at 10 atmospheres, for a total of 5 times without any issues.The struts of the deployed stent implant were protruding out into the aorta so during the post-dilatations, the nc traveler balloon catheter was pushed distal.The balloon was being inflated for a 3rd,4th and a 5th time, at 10 atmospheres to push the struts of the stent implant that were sticking into the aorta.After the balloon catheter was inflated for a 6th time at 10 atmospheres, an attempt was made to deflate the balloon catheter but the balloon did not deflate properly.Attempts were made to deflate the balloon by pulling negative a couple of times.It was confirmed on angiography the balloon was slightly deflated.However, the balloon did not fully deflate and the partially deflated balloon could not be pulled into the guiding catheter.The entire system was pulled close to the puncture site in the brachial artery and the partially inflated balloon was pierced with a needle and removed from the anatomy.Once out of the anatomy, attempts were made to remove the nc traveler balloon out of the guiding catheter but this could not be done.During the attempts to separate the balloon catheter and the guiding catheter, the hypotube was kinked/separated near the hub.There were no adverse patient effects reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual and dimensional inspections were performed on the returned device.The reported deflation issue could not be replicated in a testing environment due to the condition of the returned device.The reported difficulty removing the balloon dilatation catheter from the guiding catheter was confirmed.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 incidents from this lot.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the previously filed medwatch report, new information received stated that although it took some time to rupture the balloon and remove it from the patient anatomy, it was not clinically significant.There were no further attempts to dilate the lesion and the procedure was completed.

• 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: 7045073
• MDR Text Key: 92508037
• Report Number: 2024168-2017-09078
• 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: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 1013158-08
• Device Lot Number: 61102G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/20/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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
• Patient Outcome(s): Required Intervention