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

Model Number	BC0410C
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2018
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 the balloon ruptured during the procedure.The balloon was removed from the patient without incident.There was no reported intervention or patient injury.
Additional Manufacturer Narrative
The device was returned for evaluation.During investigation, the balloon was noted to have a linear tear.Further inspection determined that the polyimide ring was missing.Based on the investigation and provided information, the reported complaint of a ruptured balloon was confirmed.The root cause cannot be definitively determined; however, the damage to the device is consistent with over-inflation.

• Brand Name: SCEPTER C OCCLUSION BALLOON (4X10MM)
• Common Device Name: BALLOON
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7801823
• Report Number: 2032493-2018-00166
• Device Sequence Number: 2365292
• Product Code: MJN
• UDI-Device Identifier: 00842636020539
• UDI-Public: (01)00842636020539(11)171127(17)201031(10)17112713E
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 07/25/2018

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: 10/31/2020
• Device Model Number: BC0410C
• Device Catalogue Number: BC0410C
• Device Lot Number: 17112713E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR