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

Model Number	7133
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shaft leak and clotting occurred.The target lesion was located in the mid left anterior descending artery.A 3.00mm x 15mm emerge balloon catheter was advanced for dilatation.The balloon was used for multiple inflations; however, upon another inflation, a leak was noticed in the mid shaft.The patient became symptomatic and a clot was noticed.Manual thrombectomy was performed and the procedure was completed with another of same device.No further patient complications were reported and the patient recovered.
Event or Problem Description
It was reported that thrombosis occurred.The target lesion was located in the mid left anterior descending artery.A 3.00mm x 15mm emerge balloon catheter was advanced for dilatation.The balloon was used for multiple inflations; however, upon another inflation, a leak was noticed in the mid shaft.The patient became symptomatic and a clot was noticed.Manual thrombectomy was performed and the procedure was completed with another of same device.No further patient complications were reported and the patient recovered.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.There were numerous kinks to the hypotube of the device.There was contrast and blood in the inflation lumen and the balloon.There was blood in the guidewire lumen.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The device failed to inflate to the rated burst pressure.At 30.1cm from the tip of the device for a length of 2mm there was a tear in the inflation lumen causing a leak in the device.Product analysis confirmed reported shaft leak as the inflation lumen was torn.

• 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: 12571768
• Report Number: 2134265-2021-12146
• Device Sequence Number: 10980882
• Product Code: LOX
• UDI-Device Identifier: 08714729806233
• UDI-Public: 08714729806233
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/05/2021

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: 01/30/2024
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0027435529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2021
• 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: Required Intervention; Other
• Patient Sex: Unknown