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

Model Number 7135

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.

Event Description

It was reported the balloon deflation failure occurred.A 3.00mm x 30mm emerge balloon catheter was selected for use.Post inflation the balloon would not deflate.No patient complications were reported.

Manufacturer Narrative

B3: date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.Device evaluated by mfr: returned product consisted of an emerge mr balloon catheter with an attached non-bsc indeflator.The device was visually and microscopically examined.There was contrast in the inflation lumen and the balloon.The rapid port exchange was damaged.There was blood in the guidewire lumen and the balloon was loosely folded.The device was detached from the returned indeflator and was soaked for a period of time to break up the contrast and blood within the device.The device was then prepped with the returned inflation device filled with water to inflate the device to the rated burst pressure.The balloon was able to be inflated and maintained pressure as well as deflate with no issues.The device was then prepped with a bsc encore inflation device filled with water to inflate the device to the rated burst pressure.The balloon was able to be inflated and maintained pressure as well as deflate with no issues.Product analysis did not confirm the reported event, as during functional testing the balloon inflated to rated burst pressure and deflated with no issues immediately.There was unreported damage to the rapid port exchange which indicates an interaction with a guidewire or what could occur from device removal during procedural use.

Event Description

It was reported the balloon deflation failure occurred.A 3.00mm x 30mm emerge balloon catheter was selected for use.Post inflation the balloon would not deflate.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
• 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: 13025178
• MDR Text Key: 282498696
• Report Number: 2134265-2021-15951
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806431
• UDI-Public: 08714729806431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7135
• Device Catalogue Number: 7135
• Device Lot Number: 0027816581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2021
• 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