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

Model Number	7135
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2134265-2021-15951
• Device Sequence Number: 20025967
• Product Code: LOX
• UDI-Device Identifier: 08714729806431
• UDI-Public: 08714729806431
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2024
• 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown