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	10/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left main coronary artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left main coronary artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.It was further reported that the target lesion was 80% stenosed and severely calcified.The balloon was inflated twice at 10-12 atmospheres for 3 seconds each.The balloon ruptured at 12 atmospheres.
Additional Manufacturer Narrative
Device evaluated by mfr.: 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 in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.At 47mm from the tip of the device, the guidewire lumen was buckled with a length of 4mm.The buckle contained a prolapse of the lumen and a puncture hole consistent with an interaction of a guidewire.Product analysis could not confirm reported burst.Analysis shows the guidewire lumen was buckled and punctured which is consistent with an interaction with a guidewire during procedural use.The balloon folds were also tight which indicates the balloon was not inflated.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left main coronary artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.It was further reported that the target lesion was 80% stenosed and severely calcified.The balloon was inflated twice at 10-12 atmospheres for 3 seconds each.The balloon ruptured at 12 atmospheres.

• 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: 12957945
• Report Number: 2134265-2021-15476
• Device Sequence Number: 5424509
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2022

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: 01/16/2023
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0025528429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 12/09/2021; 01/18/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/17/2021; 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2020
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 78 KG