MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER XC OCCLUSION BALLOON (4X11 MM); BALLOON CATHETER

Model Number	BC0411XC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2018
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 balloon was returned for evaluation.A pinhole was identified in the balloon material at the distal balloon marker band; however, the root cause of the rupture could not be determined.
Event or Problem Description
It was reported that the balloon "ruptured" after being inflated once.There was no reported patient injury or intervention.The patient was reported to be doing okay.

• Brand Name: SCEPTER XC OCCLUSION BALLOON (4X11 MM)
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7885998
• Report Number: 2032493-2018-00186
• Device Sequence Number: 1819520
• Product Code: MJN
• UDI-Device Identifier: 00842636020591
• UDI-Public: (01)00842636020591(11)180222(17)210131(10)180222123
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2018

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: Other
• Device Expiration Date: 01/31/2021
• Device Model Number: BC0411XC
• Device Lot Number: 180222123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2018
• Initial Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1