MAUDE Adverse Event Report: MICROVENTION, INC SCEPTER C; BALLOON CATHETER

Model Number	BC0411XC-B
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the approved device history records indicated the lot met all release criteria.The investigation confirmed the reported complaint as the returned device exhibited a pinhole at the distal end of the balloon on the distal balloon bond.An investigation for the cause of the pinhole is currently being analyzed.
Event or Problem Description
It was reported that a balloon ruptured in the patient.The physician used another scepter to replace the balloon.The procedure was successful.No patient injury reported.

• Brand Name: SCEPTER C
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC; 1311 valencia ave; tustin CA 92780
• MDR Report Key: 6092712
• Report Number: 2032493-2016-00273
• Device Sequence Number: 16234095
• Product Code: MJN
• UDI-Device Identifier: 00810170018565
• UDI-Public: (01)00810170018565(11)151117(17)181117(10)15111721
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2016

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: No Information
• Device Expiration Date: 11/17/2018
• Device Model Number: BC0411XC-B
• Device Lot Number: 15111721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2016
• Initial Report FDA Received Date: 11/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 60