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

Model Number	7214
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 2.00mm x 20mm nc emerge balloon catheter was advanced for dilatation.However, the balloon ruptured when it was being inflated multiple times.No patient complications were reported.
Additional Manufacturer Narrative
Date of event: used the first day of the month of the bsc aware date since event date was not provided.
Additional Manufacturer Narrative
(b3) date of event: corrected (b)(6) 2022.(b5) updated describe event or problem.(d4) lot number: updated to 0028260538.(d4) expiration date: updated to 10/25/2023.(d4) unique identifier (udi) #: updated to (b)(4).(e1) initial reporter title: corrected from rn to dr.(e1) initial reporter first name: corrected (b)(6).(e1) initial reporter last name: corrected (b)(6).(e1) initial reporter phone: corrected (b)(6).(e1) initial reporter email: updated.(e1) initial reporter occupation: corrected from other health care professional to physician.(g1) mfr site facility name: updated from boston scientific scimed, inc to boston scientific corporation.(h4) device manufacture date: updated to 10/25/2021.
Event or Problem Description
It was reported that balloon rupture occurred.A 2.00mm x 20mm nc emerge balloon catheter was advanced for dilatation.However, the balloon ruptured when it was being inflated multiple times.No patient complications were reported.It was further reported that the 100% stenosed target lesion was located in the proximal left anterior descending artery.The balloon inflated three times for 9 atmospheres (atm) for 15 seconds, 12 atm for 9 seconds, and 12 atm for 7 seconds respectively.The balloon ruptured on the fourth inflation at 12 atm for 12 seconds.Residual stenosis was 40%.The procedure was cancelled and stenting will be done on a later date.The patient was on medical maintenance at that time and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.A 2.00mm x 20mm nc emerge balloon catheter was advanced for dilatation.However, the balloon ruptured when it was being inflated multiple times.No patient complications were reported.It was further reported that the 100% stenosed target lesion was located in the proximal left anterior descending artery.The balloon inflated three times for 9 atmospheres (atm) for 15 seconds, 12 atm for 9 seconds, and 12 atm for 7 seconds respectively.The balloon ruptured on the fourth inflation at 12 atm for 12 seconds.Residual stenosis was 40%.The procedure was cancelled and stenting will be done on a later date.The patient was on medical maintenance at that time and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There was contrast in the inflation lumen and the balloon.There was blood in the guidewire lumen and the balloon.The balloon was loosely folded.The device was soaked for a period of time to break up blood and contrast in the device.It was then prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole in the balloon located 5mm from the tip of the device.The device failed to inflate to rbp.

• Brand Name: NC 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: 13653891
• Report Number: 2134265-2022-02262
• Device Sequence Number: 5779997
• Product Code: LOX
• UDI-Device Identifier: 08714729846611
• UDI-Public: 08714729846611
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2022

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: 10/25/2023
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0028260538
• 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: 02/18/2022
• Supplement Date Received by Manufacturer: 03/07/2022; 04/07/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 03/10/2022; 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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 Sex: Unknown