MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7133

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2018

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 27 nov 2018.It was reported that shaft kink occurred.The 100% chronic total occlusion target lesion was located in the right coronary artery.A 2.50mm x 15mm emerge balloon catheter was advanced but the delivery shaft got kink.The procedure was completed with another of the same device.No patient serious injury or adverse event were reported and the patient's status was stable.However, returned device analysis revealed shaft detached/separated.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a kink 10.6cm from the hub.Microscopic examination revealed that the shaft appears to have been twisted and stretched prior to separation.The shaft is separated 126.2cm from the hub.The entire guidewire lumen, distal inflation lumen, exit notch, balloon, marker bands, and tip are all missing.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a kink in the shaft.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8145120
• MDR Text Key: 129748716
• Report Number: 2134265-2018-63756
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806219
• UDI-Public: 08714729806219
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2021
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0022099158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2018
• 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