MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER C OCCLUSION BALLOON (4X10MM); OCCLUSION BALLOON CATHETER

Model Number	BC0410C-ID
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2020
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 instructions for use (ifu) for the device states, "the scepter c and the scepter xc occlusion balloon catheters are intended for use in the peripheral and neuro vasculature where temporary occlusion is desired." additionally, the ifu identifies use of the scepter balloon for angioplasty procedures as a contraindication.The scepter was used to post-dilate a stent as a compression device, not to provide temporary vascular occlusion to stop or control blood flow, per the ifu, and the off-label application of the device represents use error.Using the scepter balloon for stent post-dilatation is an off-label use and identified as a contradiction for use in the ifu.
Event or Problem Description
It was reported that treatment was performed for an internal carotid artery aneurysm.A (non-microvention) flow-diverter stent was deployed, but it did not open proximally.During an in-stent inflation with the scepter balloon to improve the wall apposition, the balloon ruptured.There was no reported patient injury or additional intervention.
Additional Manufacturer Narrative
The scepter c balloon catheter was returned for evaluation.Visual inspection of the device found loose coil under the polyimide ring.Due to the hub's inflation port being occluded with what was likely contrast, the hub was bypassed to test balloon inflation.A pinhole leak was found 4mm distal of the proximal marker band.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: SCEPTER C OCCLUSION BALLOON (4X10MM)
• Common Device Name: OCCLUSION BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 9974919
• Report Number: 2032493-2020-00106
• Device Sequence Number: 3775961
• Product Code: MJN
• UDI-Device Identifier: 00842636020539
• UDI-Public: (01)00842636020539(11)190916(17)220831(10)190916598
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: Other
• Device Expiration Date: 08/31/2022
• Device Model Number: BC0410C-ID
• Device Catalogue Number: BC0410C
• Device Lot Number: 190916598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 50