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

Model Number	BC0420C-ID-700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, a scepter c balloon ruptured during inflation.There was no reported intervention 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 was stated to be available for analysis but has not yet been returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device is received, the investigation will be performed, and a supplemental report will be submitted.The instruction for use (ifu) include the warnings: do not exceed the maximum recommended inflation volume as balloon rupture may occur.Excessive pressure higher than 300 psi (2069kpa) may cause leakage or rupture of the balloon catheter working lumen.
Additional Manufacturer Narrative
Summary device evaluation: the investigation of the returned balloon catheter system found the device with dislodged coils; furthermore, the balloon was found with a pinhole leak during inflation testing, which is consistent with the alleged product issue.This leak would prevent the device from inflating during the preparation.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification due to over inflation.H11: correction: additional information was received via email correspondence, during the preparation of the scepter balloon, a leak was observed, and the scepter was not used for the procedure.Had this information been available at the time, this would not be deemed a reportable file.

• 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: 15080736
• Report Number: 2032493-2022-00269
• Device Sequence Number: 14482912
• Product Code: MJN
• UDI-Device Identifier: 00842429103401
• UDI-Public: (01)00842429103401(11)211005(17)240930(10)0000095238
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: 09/30/2024
• Device Model Number: BC0420C-ID-700
• Device Catalogue Number: BC0420C
• Device Lot Number: 0000095238
• 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: 07/08/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2021
• 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