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

Model Number 7134

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 78.6cm distal of the strain relief.The balloon was tightly folded.The device was prepped with an inflation device filled with water and connected to an inflation port attached to the distal portion of the shaft separation to inflate the device.No issues were detected.The device was functionally tested with a.014 inch guidewire.No issues were detected.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 18sep2019.A 2.50mm x 20mm emerge balloon catheter was received for analysis with no reported device issues.However, returned device analysis revealed shaft detached/separated.

• 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9178794
• MDR Text Key: 163030352
• Report Number: 2134265-2019-11857
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806325
• UDI-Public: 08714729806325
• 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,foreig
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2021
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0022326450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Date Manufacturer Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2018
• 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