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	04/04/2019
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 been returned to the manufacturer for analysis.The device investigation is underway.
Event or Problem Description
It was reported that the scepter c balloon ruptured during the procedure.There was no reported patient injury or intervention.The patient was reported to be doing good.
Additional Manufacturer Narrative
The balloon was inflated, and two pin holes were observed at 5 mm distal from the proximal balloon marker band.The complaint was confirmed as the reported pin hole was observed.The root cause of pin hole could not be definitely determined, but it was consistent with improper manipulation 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: 8616697
• Report Number: 2032493-2019-00143
• Device Sequence Number: 19378187
• Product Code: MJN
• UDI-Device Identifier: 00842636020546
• UDI-Public: (01)00842636020546(11)180917(17)210831(10)18091711T
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K110741
• 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): 04/21/2019

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: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: BC0415C
• Device Catalogue Number: BC0415C
• Device Lot Number: 18091711T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/21/2019
• Supplement Date Received by Manufacturer: 04/21/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 70