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

Model Number	BC0410C-ID
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A lot history trending review was performed and there were no similar complaints for this lot number.The device has been returned for evaluation.The investigation is currently ongoing.
Event or Problem Description
It was reported that during the treatment of a facial arteriovenous malformation, the balloon broke.No further information was provided regarding the procedure.There was no reported patient injury or intervention.The patient is reported to be okay.
Additional Manufacturer Narrative
The device was returned for evaluation.During investigation, the catheter was inflated with saline, and a pinhole was found on the balloon at the inflation plug.It was also noted that the tight pitch coils were removed from underneath the polyimide.In addition, the coils at the distal engage portion of the inflation lumen were stretched, and the engage tubing was noted to be thin.The purge hole to the de-airing channel transition occured normally distal to the distal balloon marker band.Based on the investigation and provided information, the reported complaint of a ruptured balloon was confirmed.The root cause is unknown; however, the device exibits evidence that it was subjected to a pinhole caused by overinflation, which exceeded its design parameters.The instructions for use (ifu) warns, "do not exceed the maximum recommended inflation volume as balloon rupture may occur.".

• Brand Name: SCEPTER C OCCLUSION BALLOON (4X10MM)
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 6985644
• Report Number: 2032493-2017-00272
• Device Sequence Number: 1196696
• Product Code: MJN
• UDI-Device Identifier: 00842636020539
• UDI-Public: (01)00842636020539(11)170502(17)200430(10)17050253U
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2017

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: 04/30/2020
• Device Model Number: BC0410C-ID
• Device Lot Number: 17050253U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/29/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 11/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1