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

Model Number	BC0420C-ID-700
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
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 not returned to the manufacturer for analysis.Procedural or post procedural images were not provided; therefore, the alleged event cannot be confirmed.If the product, additional images, or information is received at a later date, the investigation will be reopened and a supplemental report will be submitted.
Event or Problem Description
It was reported that during a procedure, it was not possible to deflate a scepter c balloon catheter.After multiple attempts, the balloon deflated.The patient is reported to be "doing well." there was no reported patient injury or intervention.
Additional Manufacturer Narrative
Additional information: d9, h6, h10 (summary of device evaluation).Summary of device evaluation: the reported complaint is confirmed.Investigation found that the balloon was unable to deflate, consistent with the alleged product issue.The inability to deflate the balloon was due to the device being over steamed prior to preparation.Multiple kinks were also found along the shaft of the catheter; 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.

• 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: 12661588
• Report Number: 2032493-2021-00416
• Device Sequence Number: 11975094
• Product Code: MJN
• UDI-Device Identifier: 00842429103401
• UDI-Public: (01)00842429103401(11)200205(17)230131(10)20020552X
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 09/21/2021

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: 01/31/2023
• Device Model Number: BC0420C-ID-700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2020
• 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