MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER C OCCLUSION BALLOON (4X20 MM); OCCLUSION BALLOON CATHETER

Model Number	BC0420C-ID-700
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
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for analysis.The investigation is currently underway.
Event or Problem Description
It was reported that during treatment of a ruptured aneurysm, the balloon was inflated, which immediately controlled bleeding.The balloon catheter was left in place for a "certain amount of time." when the balloon was then checked under fluoroscopy, the balloon was no longer inflated, appearing to have lost its volume during a time period when fluoroscopy was not activated.There was no reported patient injury as a result of the balloon deflation.The patient is reported to be "ok.".
Additional Manufacturer Narrative
Two scepter c balloon devices were returned within the same container.It could not be determined which device is associated with this complaint.Device # 1 investigation: no visible damage was observed on the returned device.Water was injected directly into the inflation lumen via the inflation port to test balloon inflation.A pinhole leak was found 6mm proximal to the proximal balloon marker band device # 2 investigation: loose coil was found under the polyimide ring.Water was injected directly into the inflation lumen via the inflation port to test balloon inflation.A pinhole leak was found 11mm proximal to the proximal balloon marker band.The conditions or circumstances that led to the damage could not be identified, 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 (4X20 MM)
• Common Device Name: OCCLUSION BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10370661
• Report Number: 2032493-2020-00195
• Device Sequence Number: 951037
• Product Code: MJN
• UDI-Device Identifier: 00842429103401
• UDI-Public: (01)00842429103401(11)200123(17)221231(10)20012353G
• 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): 07/10/2020

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: 12/31/2022
• Device Model Number: BC0420C-ID-700
• Device Lot Number: 20012353G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/05/2020
• 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