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

Model Number	BC0410C
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Vascular System (Circulation), Impaired (2572)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The balloon catheter was returned for analysis.Upon investigation, the catheter was observed to be ruptured 5.5cm from the tip.Both the guidewire lumen and inflation lumen were ruptured, and the guidewire lumen showed signs of being kinked.Since the rupture on both lumens were located at the same location and sign of kinking was observed, it was highly likely the catheter shaft was damaged (kinked or crushed) at the location before the onyx was injected, causing it to lose structural integrity and became vulnerable to burst.Based upon investigation findings and available information, the complaint of a ruptured balloon catheter was confirmed.The root cause of the issue could not be definitely determined, but it was suggested by the investigation that kinking of the catheter could be the cause of the burst.
Event or Problem Description
It was reported that during the treatment of a middle meningeal artery, onyx was delivered through the scepter c balloon catheter, and the balloon catheter ruptured approximately 10cm from the balloon.Onyx leaked from the catheter and caused complete occlusion of the sphenopalatine artery.There was no reported issue with the removal of the balloon catheter.The patient's condition was reported to be at baseline.

• Brand Name: SCEPTER C OCCLUSION BALLOON (4X10MM)
• Common Device Name: BALLOON
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8589124
• Report Number: 2032493-2019-00127
• Device Sequence Number: 19229186
• Product Code: MJN
• UDI-Device Identifier: 00842636020539
• UDI-Public: (01)00842636020539(11)181204(17)211130(10)18120412K
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K110741
• 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
• Report Date (Section B): 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/30/2021
• Device Model Number: BC0410C
• Device Catalogue Number: BC0410C
• Device Lot Number: 18120412K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability