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

Model Number 7133

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.A 2.50mm x 15mm fg emerge balloon catheter was advanced for treatment.However, when the device was inserted, the shaft bent and came apart from the balloon when it was removed.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube, inflation lumen, and guidewire lumen.The hypotube is separated 80.9cm from the hub.Microscopic examination revealed no additional damages.The balloon is still tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that shaft break occurred.A 2.50mm x 15mm fg emerge balloon catheter was advanced for treatment.However, when the device was inserted, the shaft bent and came apart from the balloon when it was removed.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 8332953
• MDR Text Key: 135949246
• Report Number: 2134265-2019-01164
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806219
• UDI-Public: 08714729806219
• Combination Product (y/n): N
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

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: 07/02/2021
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0022888660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: 03/22/2019
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1