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	07/10/2020
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 balloon-assisted coil embolization was performed for an internal carotid artery aneurysm.During the balloon inflation, the balloon ruptured.The balloon was removed from the patient and replaced without incident.There was no reported patient injury or additional intervention.The patient's current condition is reported to be "good.".
Additional Manufacturer Narrative
The scepter balloon was returned for evaluation.Visual inspection of the device revealed multiple areas of damage to the catheter.Upon inflation of the balloon, a pinhole was present 5mm 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 occur due to over inflation.The root cause is unknown.

• 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: 10439806
• Report Number: 2032493-2020-00220
• Device Sequence Number: 14193914
• 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: UP
• 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): 07/23/2020

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: Other
• 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: 08/03/2020
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 100