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

Model Number	BC0411XC-ID
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Microvention determined that the issue was confirmed to be isolated to this small lot and was due to a human error.The products are manufactured in tightly controlled environment, the product bioburden level is regularly monitored and kept at very low level.Awareness training has been performed to the personnel involved in the incident.One other scepter xc balloon from the same lot was sent to the same customer (total of three devices).The report has been submitted as mfr report # 2032493-2017-00174.There are no other scepter xc balloons with this lot number that exist in the field.This device was used during the same procedure as reported on mfr.Report # 2032493-2017-00176.
Event or Problem Description
It was identified that two scepter xc balloons were inadvertently missed from the terminal sterilization process and shipped to a customer.The physician was immediately notified.Two scepter xc balloons were selected for use on (b)(6) 2017 in a patient that was classified as hh1, clinically in good condition, who was undergoing treatment for a ruptured aneurysm.The first scepter balloon was selected for treatment, but was not used due to the presence of a kink on the shaft.The second scepter balloon was used in the patient to assist with coil placement inside the aneurysm sac (balloon remodeling technique).The decision was made to administer prophylactic treatment with a broad-spectrum antibiotic (tazobac) post-procedure.Currently, the patient does not exhibit signs of infection; there is no elevation of crp or leukocytes.The patient is being closely monitored by the physician.

• Brand Name: SCEPTER XC OCCLUSION BALLOON (4X11 MM)
• Common Device Name: BALLOON
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 6803001
• Report Number: 2032493-2017-00175
• Device Sequence Number: 11193248
• Product Code: MJN
• UDI-Device Identifier: 00842636020591
• UDI-Public: (01)00842636020591(11)160808(17)190731(10)160808GC3
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2017

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: 07/31/2017
• Device Model Number: BC0411XC-ID
• Device Lot Number: 160808GC3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1