MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER MINI; VASCULAR CLAMP

Model Number BC0210M

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Headache (1880); Rupture (2208)

Event Date 04/26/2021

Event Type  Injury  

Manufacturer Narrative

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 investigation leads to the conclusion that the events, as stated in the complaint record, did occur and the complaint of ruptured balloon was confirmed.The balloon was found to be ruptured.The rupture is consistent with the balloon being overinflated as indicated in the complaint description.The instructions for use (ifu) warns: "do not exceed the maximum recommended inflation volume as balloon rupture may occur." the instructions for use (ifu) identifies intracerebral/intracranial hemorrhage as a potential complication associated with use of the device.

Event Description

It was reported that the scepter mini balloon catheter was advanced to the target location in the distal superior cerebellar artery (sca).The balloon was inflated with no issues, then deflated.Multiple angiographic runs were performed (contrast injected through the balloon).The balloon was reinflated and extravasation was discovered.The vessel was ruptured.Heparin was reversed and the procedure was aborted.Physicians think that they put too much pressure on the balloon inflation, causing the rupture.They stated that the balloon itself was not the cause of the rupture.Inflation pressure at the time of the rupture is unknown.The patient was doing fine.

• Brand Name: SCEPTER MINI
• Type of Device: VASCULAR CLAMP
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 11882350
• MDR Text Key: 252687285
• Report Number: 2032493-2021-00184
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00816777025821
• UDI-Public: (01)00816777025821(11)201104(17)211031(10)20110412F
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: BC0210M
• Device Lot Number: 20110412F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention