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	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(e1) initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The patient was presented with chest pain and percutaneous coronary intervention was performed.The 90% stenosed, 3.5x25, concentric, de novo target lesion with a bend of <=45 degrees was located in the mildly tortuous and moderately calcified left anterior descending artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, during inflation at 6 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The patient was presented with chest pain and percutaneous coronary intervention was performed.The 90% stenosed, 3.5x25, concentric, de novo target lesion with a bend of <=45 degrees was located in the mildly tortuous and moderately calcified left anterior descending artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, during inflation at 6 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient status was stable.It was further reported that the balloon ruptured on the second inflation for 5 seconds.
Additional Manufacturer Narrative
(e1) (b)(6).
Additional Manufacturer Narrative
(e1) initial reporter phone: (b)(6).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 the balloon was tightly folded.The rapid port exchange (rpe) was torn just enough to separate the inflation lumen and the guidewire lumen.The distance of the tear is outside the bond of the inflation lumen and guidewire lumen which indicates the device would leak upon inflation.Product analysis confirmed the reported burst, as there was a tear in the rapid port exchange which extended through both lumens and would cause a leak upon device inflation.
Event or Problem Description
It was reported that balloon rupture occurred.The patient was presented with chest pain and percutaneous coronary intervention was performed.The 90% stenosed, 3.5x25, concentric, de novo target lesion with a bend of <=45 degrees was located in the mildly tortuous and moderately calcified left anterior descending artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, during inflation at 6 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient status was stable.It was further reported that the balloon ruptured on the second inflation for 5 seconds.

• 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: 17204358
• Report Number: 2124215-2023-33169
• Device Sequence Number: 12122781
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2023

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: 03/11/2024
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0027669194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 07/02/2023; 08/22/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/06/2023; 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 50 KG