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

Model Number 7132

Device Problems Material Puncture/Hole (1504); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 08/02/2018

Event Type  malfunction  

Event Description

It was reported that shaft hole/perforation occurred.A 2.75mm x 12mm emerge balloon catheter was selected for use.However, during inspection, a raised metal spot on the shaft was noted and the balloon was not used.The procedure was completed with a different device.No patient complications were reported.

Event Description

It was reported that shaft hole/perforation occurred.A 2.75mm x 12mm emerge balloon catheter was selected for use.However, during inspection, a raised metal spot on the shaft was noted and the balloon was not used.The procedure was completed with a different device.No patient complications were reported.The device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed three kinks.The kinks are located 32.2cm, 64.5cm, and 99cm from the hub.Microscopic examination did not reveal any damage.Although it was reported that the device was not used, the presence of blood and contrast media in the guidewire lumen is indicative of handling beyond simply unpackaging the device, as was reported.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported raised metal spot on 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
• MDR Report Key: 7860686
• MDR Text Key: 119791473
• Report Number: 2134265-2018-60787
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806110
• UDI-Public: 08714729806110
• 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: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2021
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0022348390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Date Manufacturer Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1