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

Model Number	7134
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bradycardia (1751); Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)
Date of Event	09/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred requiring an additional intervention.The target lesion was located in right coronary artery (rca).A 3.00mm x 20mm emerge balloon catheter was inserted and inflated.However, when another balloon was inserted to follow up, it was noticed that the shaft broke off in the mid rca and lodged in the artery.Physician tried to retrieve the balloon but was unsuccessful.Patient bradycardia with compressions and patient received additional radiation exposure.A covered stent and a drug-eluting stent were then placed to secure broken piece against the wall of the artery and the procedure was completed.There were no patient complications reported and the patient was fully recovered.
Additional Manufacturer Narrative
Device evaluated of by manufacturer.: the complaint device was not received at the complaint investigation site for analysis.However, photo media was attached in complaint record.Media depicted shaft damage as the guidewire lumen was buckled and stretched.The most distal portion was also detached as there was just a balloon portion found within the media provided.There was blood within the lumen which indicates use of the device past preparation.The shaft inflation lumen was also detached just distal to the bicomponent weld of the device.H3 other text : photo media was attached in complaint record.
Event or Problem Description
It was reported that shaft break occurred requiring an additional intervention.The target lesion was located in right coronary artery (rca).A 3.00mm x 20mm emerge balloon catheter was inserted and inflated.However, when another balloon was inserted to follow up, it was noticed that the shaft broke off in the mid rca and lodged in the artery.Physician tried to retrieve the balloon but was unsuccessful.Patient bradycardia with compressions and patient received additional radiation exposure.A covered stent and a drug-eluting stent were then placed to secure broken piece against the wall of the artery and the procedure was completed.There were no patient complications reported and the patient was fully recovered.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15531829
• Report Number: 2124215-2022-37936
• Device Sequence Number: 14773719
• Product Code: LOX
• UDI-Device Identifier: 08714729806349
• UDI-Public: 08714729806349
• 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): 11/08/2022

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: 02/09/2025
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0029597232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male