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

Model Number	7134
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left cardiac coronary artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilation.However, during inflation at 12 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported, and the patient was stable.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).
Additional Manufacturer Narrative
Device evaluated by mfr.: fg emerge mr, us 2.00mm x 20mm was returned for analysis.A visual examination of the balloon identified no issues.No issues with the hypotube shaft.Visual examination of the shaft polymer extrusion identified no issues.A detailed microscopic examination of the balloon material identified a pinhole over the proximal edge of the distal markerband.Tip showed no signs of tip damage.A microscopic examination of the distal and proximal markerbands identified no damage.An attempt was made to inflate the balloon however inflation liquid was seen coming from the pinhole leak over the proximal edge of the distal markerband.The encore device was verified before and after use using the druck gauge.E1 initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left cardiac coronary artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilation.However, during inflation at 12 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported, and the patient was stable.

• 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: 19483678
• Report Number: 2124215-2024-34154
• Device Sequence Number: 7905981
• Product Code: LOX
• UDI-Device Identifier: 08714729806301
• UDI-Public: 08714729806301
• 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
• Report Date (Section B): 08/20/2024

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: 09/07/2024
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0028658022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 08/10/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 69 KG