MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER C OCCLUSION BALLOON (4X10MM); OCCLUSION BALLOON CATHETER

Model Number	INTERVENTIONAL NEURORAADIOLOGISTBC0410C
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device was not returned to the manufacturer; therefore, a product evaluation could not be performed.The root cause is unknown.
Event or Problem Description
It was reported that during balloon-assisted treatment of an extracranial cognard type iii davf, the scepter balloon would not deflate after the phil was injected.The vessel was ruptured in order to remove the balloon.The fistula was shut down completely and the patient was reported to have done well post-procedure.
Additional Manufacturer Narrative
The balloon catheter was inflated with saline, and a pin hole was observed at 10mm distal from the proximal balloon marker band.No excess resistance was felt when inflating the balloon, suggesting the inflation lumen/inflation plug worked as expected.The complaint could not be confirmed because the balloon was ruptured and could not be inflated for deflation test.The reported complaint is non-verifiable.The complaint stated that the balloon would not deflate.The physical evaluation of the returned scepter c found a pinhole on the balloon that prevented the balloon from inflating.This pinhole prevented the testing needed to verify the reported complaint that the balloon would not deflate.The investigation could not determine when the pinhole occurred, but it is likely that excessive handling of the device caused the pinhole, likely post-procedure.

• Brand Name: SCEPTER C OCCLUSION BALLOON (4X10MM)
• Common Device Name: OCCLUSION BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8525172
• Report Number: 2032493-2019-00086
• Device Sequence Number: 13928144
• Product Code: MJN
• UDI-Device Identifier: 00842636020539
• UDI-Public: (01)00842636020539(11)180702(17)210630(10)18070255K
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2021
• Device Model Number: INTERVENTIONAL NEURORAADIOLOGISTBC0410C
• Device Catalogue Number: BC0410C
• Device Lot Number: 18070255K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR