MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER C OCCLUSION BALLOON (4X10 MM); EMBOLIZATION COIL

Model Number	BC0410C
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records 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 has been returned to the manufacturer.The investigation is currently underway.
Event or Problem Description
It was reported that the balloon ruptured.No further information was provided regarding the procedure.There was no reported intervention or patient injury.The patient's condition was reported to be "normal.".
Additional Manufacturer Narrative
The device was returned for evaluation.During investigation, the balloon was inflated with saline.Upon inflation, a pinhole was found in the balloon material 7mm distal to the proximal balloon marker band.Based on the investigation and provided information, the reported complaint of a ruptured balloon was confirmed.The root cause cannot be determined.

• Brand Name: SCEPTER C OCCLUSION BALLOON (4X10 MM)
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7643477
• Report Number: 2032493-2018-00123
• Device Sequence Number: 1555561
• Product Code: MJN
• UDI-Device Identifier: 00842636020539
• UDI-Public: (01)00842636020539(11)170817(17)200731(10)17081711L
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/31/2018

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: Physician
• Device Expiration Date: 07/31/2020
• Device Model Number: BC0410C
• Device Lot Number: 17081711L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 61