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

Catalog Number 1012449-12

Device Problems Detachment Of Device Component (1104); Material Rupture (1546)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/18/2017

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 was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported the procedure was to treat a lesion with heavy calcification in the diagonal coronary artery.A 3.0 x 12 mm nc trek balloon catheter was advanced through a previously implanted stent without resistance to the target lesion.The balloon was inflated to 18 atmospheres (atms); however, a circumferential rupture occurred and the distal part of the balloon with the inner-member separated.Reportedly, there was no resistance during removal of the balloon catheter after it ruptured.There was no attempt to retrieve the separated balloon/inner-member as it was over the takeoff [ostium] of the diagonal and the physician thought more damage could be done to the vessel during the attempt to remove the separated balloon/inner-member.Therefore, the patient was hospitalized overnight for observation and administered heparin.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual inspection and scanning electron microscopy (sem) analysis were performed on the returned device.The reported balloon rupture, balloon separation and inner member separation were confirmed.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 incidents from this lot.The investigation determined that the reported balloon rupture, balloon separation and inner member separation appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• 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: 6937884
• MDR Text Key: 89143999
• Report Number: 2024168-2017-08113
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151866
• UDI-Public: 08717648151866
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 1012449-12
• Device Lot Number: 70520G3
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 78 YR