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

Model Number	7141
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon leak occurred.The 70% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.A 2.50mm x 8mm emerge balloon catheter was selected for use, but it could not reach the lesion and it was noted that the balloon was leaking gas.The procedure was completed with another of same device.There were no patient complications reported.Patient was stable.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon leak occurred.The 70% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.A 2.50mm x 8mm emerge balloon catheter was selected for use, but it could not reach the lesion and it was noted that the balloon was leaking gas.The procedure was completed with another of same device.There were no patient complications reported.Patient was stable.It was further reported that the balloon was leaking outside the patients body.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter phone: +(b)(6).
Event or Problem Description
It was reported that balloon leak occurred.The 70% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.A 2.50mm x 8mm emerge balloon catheter was selected for use, but it could not reach the lesion and it was noted that the balloon was leaking gas.The procedure was completed with another of same device.There were no patient complications reported.Patient was stable.It was further reported that the balloon was leaking outside the patients body.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19164643
• Report Number: 2124215-2024-22714
• Device Sequence Number: 7873605
• Product Code: LOX
• UDI-Device Identifier: 08714729807131
• UDI-Public: 08714729807131
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2024

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: 09/14/2024
• Device Model Number: 7141
• Device Catalogue Number: 7141
• Device Lot Number: 0030154896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 04/30/2024; 07/12/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/01/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 70 KG