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

Model Number 7312

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr.: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a longitudinal tear in the inflation lumen and guidewire lumen 23.6cm from the tip and approximately 1cm long.Microscopic examination revealed that the tip is damaged.The guidewire lumen is buckled 3.1cm from the tip for approximately 1.8cm and 5.1cm from the tip for approximately 1.4cm.There is contrast present in the inflation lumen and balloon.The balloon is loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a longitudinal tear in the inflation lumen and guidewire lumen.

Event Description

It was reported that shaft hole occurred.The target lesion was located in the left main trunk to left anterior descending artery.A 5.50mm x 12mm nc emerge balloon catheter was advanced for post-dilation.However, during third inflation, the air got inside the indeflator.A negative pressure was not applied during rewrapping.When the shaft was checked, it was confirmed that there was a hole in the shaft.The device was removed from the patient's body.The procedure was completed with another of the same device.No patient serious injury or adverse event were reported.

• Brand Name: NC 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: 8326204
• MDR Text Key: 135734702
• Report Number: 2134265-2019-00918
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2020
• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 0022667211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2018
• 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
• Treatment: INFLATION DEVICE: ENCORE BSJ; STENT: RESOLUTE ONYS MEDTRONIC