MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER C OCCLUSION BALLOON; VASCULAR CLAMP

Model Number	BC0410C-ID-700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional 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 device was returned to the manufacturer for evaluation.The investigation is ongoing.
Event or Problem Description
It was reported that during a procedure, a scepter balloon ruptured.There was no injury to the patient.
Additional Manufacturer Narrative
Device evaluation summary: investigation found kinks along the shaft of the catheter, and a ruptured balloon, consistent with the alleged product issue.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is a result of the inflation pressure exceeding the strength of the balloon wall.

• Brand Name: SCEPTER C OCCLUSION BALLOON
• Common Device Name: VASCULAR CLAMP
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12443260
• Report Number: 2032493-2021-00364
• Device Sequence Number: 3655288
• Product Code: MJN
• UDI-Device Identifier: 00842429103388
• UDI-Public: (01)00842429103388(11)210510(17)240430(10)210510575
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K110741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 04/30/2024
• Device Model Number: BC0410C-ID-700
• Device Lot Number: 210510575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 63