MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER C OCCLUSION BALLOON (4X11MM); OCCLUSION BALLOON CATHETER

Model Number	BC0411XC-ID
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.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.The device has not been returned to the manufacturer for analysis.
Event or Problem Description
It was reported that while using the balloon to assist in coil embolization of an aneurysm, the balloon suddenly deflated.There was no reported patient injury.The patient's current condition is reported to be "ok.".
Additional Manufacturer Narrative
Two scepter xc balloon devices were returned within the same container.It could not be determined which device is associated with this complaint.Device # 1 investigation: visual investigation of the returned device found loose coil under the polyimide ring.Due to the hub's inflation port being occluded with what was most likely contrast, the hub was bypassed to test balloon inflation.A pinhole leak was found 2mm proximal to the proximal balloon marker band.Device # 2 investigation: visual investigation of the returned device found loose coil under the polyimide ring.Due to the hub's inflation port being occluded with what was most likely contrast, the hub was bypassed to test balloon inflation.A pinhole leak was found 1mm distal to the proximal balloon marker band.The physical evaluation of the devices could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification, which could have occurred due to handling or over-inflation.

• Brand Name: SCEPTER C OCCLUSION BALLOON (4X11MM)
• Common Device Name: OCCLUSION BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10318042
• Report Number: 2032493-2020-00183
• Device Sequence Number: 11491045
• Product Code: MJN
• UDI-Device Identifier: 00842636020591
• UDI-Public: (01)00842636020591(11)191118(17)221031(10)191118523
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2020

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: 10/31/2022
• Device Model Number: BC0411XC-ID
• Device Catalogue Number: BC0411XC
• Device Lot Number: 191118523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR