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

Model Number	BC0411XC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.A lot history trending review was performed and there were no similar complaints for this lot number.The device has been returned to the manufacturer.The investigation is underway.
Event or Problem Description
It was reported that the balloon deflated during the procedure.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
The sales representative who originally reported the complaint provided further information on 6/20/19 that the balloon did not burst as indicated in the initial medwatch (mfr report # 2032493-2019-00156), but rather deflated slowly.This is no longer considered an mdr reportable complaint per 21 cfr 803, as a slowly deflating balloon is not likely not contribute to a death or serious injury should the event recur.Corrected data: (g4) no date.Not mdr reportable.The device was inspected and had no visible damage.The balloon was then inflated with saline and was shown to inflate and hold inflation, as expected, with no issues.The reported complaint could not be confirmed, as the balloon functioned as expected during the investigation.

• 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: 8714544
• Report Number: 2032493-2019-00156
• Device Sequence Number: 14071704
• Product Code: MJN
• UDI-Device Identifier: 00842636020591
• UDI-Public: (01)00842636020591(11)170323(17)200229(10)170323TC2
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K113698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: BC0411XC
• Device Catalogue Number: BC0411XC
• Device Lot Number: 170323TC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1