MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER C OCCLUSION BALLOON (4X15 MM); OCCLUSION BALLOON CATHETER

Model Number	BC0415C-ID
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance 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 received by the manufacturer for evaluation.
Event or Problem Description
It was reported that the balloon could not be deflated during the procedure.The balloon was removed through the intermediate catheter without incident.There was no reported patient injury.
Additional Manufacturer Narrative
The investigation of the returned scepter found the catheter to be crushed beneath the hub.This damage restricted the inflation lumen, which resulted in slower inflation and deflation.The hub was bypassed and the balloon inflated and deflated normally.The conditions or circumstances that led to the damage could not be identified, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: SCEPTER C OCCLUSION BALLOON (4X15 MM)
• Common Device Name: OCCLUSION BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 11069631
• Report Number: 2032493-2020-00392
• Device Sequence Number: 11460271
• Product Code: MJN
• UDI-Device Identifier: 00842636020546
• UDI-Public: (01)00842636020546(11)191101(17)221031(10)19110152U
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2021

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: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: BC0415C-ID
• Device Catalogue Number: BC0415C
• Device Lot Number: 19110152U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 02/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1