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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance 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 has been returned to the manufacturer for analysis.The investigation is currently underway.
Event or Problem Description
It was reported that the balloon ruptured during the procedure.The device was removed in its entirety.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
The investigation of the returned catheter found the balloon ruptured 3.4cm from the distal tip, as well as additional damage that is consistent with occurring during the retrieval process.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 excessive forces.

• 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 92656
• MDR Report Key: 10659645
• Report Number: 2032493-2020-00281
• Device Sequence Number: 14239370
• Product Code: MJN
• UDI-Device Identifier: 00842429103401
• UDI-Public: (01)00842429103401(11)200303(17)230228(10)200303579
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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: 02/28/2023
• Device Model Number: BC0420C-ID-700
• Device Lot Number: 200303579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1