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

Model Number	BC0415C-ID
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2019
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 returned to the manufacturer for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during balloon-assisted coiling of an internal carotid artery aneurysm, the balloon was not deflating rapidly after inflating and deflating 2-3 times.The device was removed from the patient without incident.There was no reported intervention or patient injury.
Additional Manufacturer Narrative
The device was returned for evaluation.Visual inspection did not find any damage to the balloon or catheter shaft.The balloon's inflation was tested and partially inflated with water.Continued injection filled the balloon with water while removing air from balloon until balloon was completely filled with water.The balloon deflated normally.The reported complaint is unconfirmed.The investigation of the returned scepter c balloon system found the device to function normally; the balloon was able to be inflated and deflated without issue.The reported event is consistent with improper sealing of the purge hole during preparation, which would result in blood being drawn into the balloon during repeated deflation, resulting in a slower deflation time.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report or the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.

• Brand Name: SCEPTER C OCCLUSION BALLOON (4X15 MM)
• Common Device Name: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9359987
• Report Number: 2032493-2019-00276
• Device Sequence Number: 2403451
• Product Code: MJN
• UDI-Device Identifier: 00842636020546
• UDI-Public: (01)00842636020546(11)181121(17)211031(10)18112111Q
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K110741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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: 10/31/2021
• Device Model Number: BC0415C-ID
• Device Catalogue Number: BC0415C
• Device Lot Number: 18112111Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR