MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER C OCCLUSION BALLOON (4X15MM)

Model Number	BC0415C
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.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 has not been returned to the manufacturer.Therefore, a product analysis could not be performed.The root cause is unknown.
Event or Problem Description
It was reported that the balloon suddenly deflated in the patient during the procedure.There was no reported intervention, patient injury, or health damage.
Additional Manufacturer Narrative
Corrected data: device received and evaluated.The device was received for evaluation.The hub was found occluded with contrast solution; the hub was bypassed and balloon was inflated.A pinhole was found at 6mm from the proximal balloon marker band.The root cause of the pinhole could not be definitely determined, but is consistent with improper preparation and over-inflation of the balloon.

• Brand Name: SCEPTER C OCCLUSION BALLOON (4X15MM)
• Common Device Name: BALLOON
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8823770
• Report Number: 2032493-2019-00176
• Device Sequence Number: 19603445
• Product Code: MJN
• UDI-Device Identifier: 00842636020546
• UDI-Public: (01)00842636020546(11)180425(17)210331(10)180425551
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K121785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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: 03/31/2021
• Device Model Number: BC0415C
• Device Catalogue Number: BC0415C
• Device Lot Number: 180425551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1