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

Model Number	7132
Medical Device Problem Codes	Deflation Problem (1149); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon deflation failure occurred and a perforation occured.The target lesion was located in the left circumflex artery.A 3.00mm x 12mm emerge balloon catheter was advanced for dilation.However, it was noted that the balloon would not deflate.The device was withdrawn while inflated.A perforation occurred.The patient coded and was then revived.The physician then performed a pericardiocentesis was performed as a pericardial effusion was observed.A non-bsc covered stent was placed.After the procedure, the patient was transported to the intensive care unit.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.The hypotube of the device has numerous severe kinks.There was contrast in the inflation lumen and balloon.There was blood in the guidewire lumen.The balloon was loosely folded, and the body of the balloon was twisted.The distal portion of the balloon was slightly prolapsed with blood in prolapsed folds.The device was then prepped with an 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.
Event or Problem Description
It was reported that balloon deflation failure occurred and a perforation occured.The target lesion was located in the left circumflex artery.A 3.00mm x 12mm emerge balloon catheter was advanced for dilation.However, it was noted that the balloon would not deflate.The device was withdrawn while inflated.A perforation occurred.The patient coded and was then revived.The physician then performed a pericardiocentesis was performed as a pericardial effusion was observed.A non-bsc covered stent was placed.After the procedure, the patient was transported to the intensive care unit.No further 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 johnshon ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12698506
• Report Number: 2134265-2021-13406
• Device Sequence Number: 16484728
• Product Code: LOX
• UDI-Device Identifier: 08714729806127
• UDI-Public: 08714729806127
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2024
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0027747943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 56 YR
• Patient Sex: Male