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

Model Number BC0420C

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2017

Event Type  malfunction  

Event Description

The balloon was found to have a hole while table prepping the device.The device did not reach or impact the patient in any way.Manufacturer response for occlusion balloon catheter (per site reporter).I contacted the manufacturer and they gave me the representative's phone and email to contact.I sent an email and did not hear from him.Weeks later, i left a voicemail message stating that i need to return the device back for investigation.

• Brand Name: SCEPTER C
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICROVENTION INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6739612
• MDR Text Key: 80883527
• Report Number: 6739612
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Expiration Date: 02/11/2018
• Device Model Number: BC0420C
• Device Catalogue Number: BC0420C
• Device Lot Number: 151102UC3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2017
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO