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

Model Number	7132
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device detachment occurred.During unpacking of a 2.50mm x 12mm emerge balloon catheter, the balloon tip was bent and the device was noted to be fractured.
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that device detachment occurred.During unpacking of a 2.50mm x 12mm emerge balloon catheter, the balloon tip was bent and the device was noted to be fractured.
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.The returned product consisted of an emerge mr balloon catheter from boston scientific batch 28840085.The device was microscopically and visually examined.There was contrast in the inflation lumen and the balloon was tightly folded.The tip of the device was damaged and prolapsed.

• 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14550617
• Report Number: 2134265-2022-06067
• Device Sequence Number: 6774231
• Product Code: LOX
• UDI-Device Identifier: 08714729806103
• UDI-Public: 08714729806103
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/21/2022

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: 10/06/2024
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0028840085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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