MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER C; BALLOON CATHETER

Model Number	BC0415C-ID-700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during attempt to inflate the scepter balloon inside target vessel (ica) under fluoroscopy, the balloon did not appear to inflate and was removed from the patient, where it was found to have ruptured.There was no report of harm or injury to the patient.
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device has not yet been returned to the manufacturer for analysis, therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) includes this warning: during air-purging of catheter lumen, inject fluid slowly otherwise balloon may rupture.
Additional Manufacturer Narrative
Additional information: h10 (summary device evaluation).Summary device evaluation: the investigation of the returned balloon catheter system found no rupture on the balloon; however, it exhibited a pin hole leak during inflation testing.A pin hole leak would result in difficulty inflating the device as described in the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the pin hole, but it is consistent with the balloon experiencing forces over specification.

• Brand Name: SCEPTER C
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13983878
• Report Number: 2032493-2022-00125
• Device Sequence Number: 14951157
• Product Code: MJN
• UDI-Device Identifier: 00842429103395
• UDI-Public: (01)00842429103395(11)201008(17)230930(10)201008541
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K110741
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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: 09/30/2023
• Device Model Number: BC0415C-ID-700
• 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: 03/09/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2020
• 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 Sex: Unknown