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
(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed, 3.80mm x 20mm, concentric, de novo target lesion with a bend of <= 45 degrees was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured at nominal pressure.The device was removed, and the procedure was completed with another of same device.There were no patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed, 3.80mm x 20mm, concentric, de novo target lesion with a bend of <= 45 degrees was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured at nominal pressure.The device was removed, and the procedure was completed with another of same device.There were no patient complications were reported and the patient status was stable.It was further reported that the balloon was inflated three times at 14 atmospheres for 5 to 8 seconds.
Additional Manufacturer Narrative
E1 - (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6) b5 - describe event or problem updated.Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.There was contrast in the inflation lumen and the balloon.The balloon was tightly folded.The device was prepped with a new inflation device filled with water and connected to the inflation port to inflate the device.The device inflated and deflated to rated burst pressure with no issue.There was no damage or irregularities found to the device.Product analysis could not confirm reported event as the device inflated to rated burst pressure and deflated with no issue.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed, 3.80mm x 20mm, concentric, de novo target lesion with a bend of <= 45 degrees was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured at nominal pressure.The device was removed, and the procedure was completed with another of same device.There were no patient complications were reported and the patient status was stable.It was further reported that the balloon was inflated three times at 14 atmospheres for 5 to 8 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: 17206285
• Report Number: 2124215-2023-33284
• Device Sequence Number: 20218922
• 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): 09/11/2023

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: 03/16/2025
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0029796993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 07/02/2023; 08/21/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/05/2023; 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 55 KG