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

Model Number 7171

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that shaft hole/perforation occurred.The target lesion as located in the septal artery.A 1.50mm x 12mm emerge balloon catheter was advanced for dilatation over the guidewire.However, it was noted that the "wire came out from the outside of otw balloon".The physician felt uncomfortable using the device so it was exchanged for another 1.50mm x 12mm emerge balloon catheter and the procedure was completed.No patient complications were reported.

Event Description

It was reported that shaft hole/perforation occurred.The target lesion as located in the septal artery.A 1.50mm x 12mm emerge balloon catheter was advanced for dilatation over the guidewire.However, it was noted that the "wire came out from the outside of otw balloon".The physician felt uncomfortable using the device so it was exchanged for another 1.50mm x 12mm emerge balloon catheter and the procedure was completed.No patient complications were reported.Returned product consisted of an emerge balloon catheter with a syringe.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed that the tip is damaged.There is blood present in the guide wire lumen and hub.The balloon was loosely folded prior to inflation testing.The guide wire used in the clinical procedure was not returned with the device.The test guide wire was advanced into the guide wire lumen and was able to pass through.The device was also pressure tested to find any possible leaks.The balloon was inflated and could hold pressure for 5 minutes.Inspection of the remainder of the device presented no other damage or irregularities.

Manufacturer Narrative

Age at time of event: 18 years or older.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/17/2018 11:55 am ct.The report number is being corrected from: 2134265-2018-64061to: 2134265-2018-63067.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8101769
• MDR Text Key: 128276178
• Report Number: 2134265-2018-63067
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K083094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

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: 09/16/2020
• Device Model Number: 7171
• Device Catalogue Number: 7171
• Device Lot Number: 0022665132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/26/2018
• Supplement Dates Manufacturer Received: 11/28/2018
• Supplement Dates FDA Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 62