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

Catalog Number 1012454-12

Device Problems Deflation Problem (1149); Leak/Splash (1354); Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2018

Event Type  Injury  

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 investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion located in the right coronary artery.After stenting of the lesion with the first stent and post-dilatation with the 4.5 x 12 mm nc trek balloon catheter, it was observed that the lesion was not fully covered; therefore, a second stent was placed distally overlapping the first stent.The same 4.5 x 12 mm nc trek was used for post-dilatation of the stents; however, after deflation of the balloon it was observed that the re-wrap of the balloon was poor, which resulted in difficulty removing the balloon from the anatomy.The balloon was pulled into the aorta where it was inflated and deflated several times.After the last inflation was performed the balloon would not deflate.The decision was made to inflate the balloon to 18 atms to rupture the balloon; however, this failed, but a rupture of the shaft was observed as evidenced by leaking contrast.The leak was by the guide wire exit notch.The balloon was still partially inflated at the tip of the balloon; however, was able to be pulled to the tip of the guiding catheter and removed as one unit.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction- device status changed from returning to not returned.The device was not returned for evaluation.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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported deflation and folded (winged) balloon; however, the reported difficulty removing the device from the anatomy and the leak appear 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.A video clip was received and reviewed by an abbott vascular clinical specialist.The analysis concluded the video clip provided for this incident clearly shows blood within the lumen of the catheter and within the deflated balloon indicating a leak within the system.The distal shaft of the catheter appears to be stretched although measurements cannot be determined from the imaging.The incident report supports retraction against resistance although it is not stated.The incident describes poor rewrap of the balloon and difficulty removing the balloon from the anatomy with several subsequent inflation/deflation cycles with the balloon in the aorta.The purpose of the inflation/deflations within the aorta are not driven by clinical treatment, and it is unknown why this action took place within the patient anatomy.

• Brand Name: NC TREK 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: 7631005
• MDR Text Key: 112085791
• Report Number: 2024168-2018-04864
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 1012454-12
• Device Lot Number: 80206G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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
• Patient Age: 64 YR
• Patient Weight: 91