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	06/26/2019
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 ruptured in the patient during the procedure.There was no reported intervention, patient injury, or health damage.
Additional Manufacturer Narrative
Additional information / b5: it was confirmed that the inflation pressure at the time of rupture could not be determined.Corrected data: (d10)(h3) - device received and analyzed corrected data: (e1) - spelling of contact's first name corrected data (e3) - other health care professional corrected data: (d5) - operator's title the balloon was inflated using the inflation lumen at the hub, the balloon had a pinhole at the proximal balloon marker band the reported complaint is confirmed.The physical evaluation of the returned scepter c found a pinhole on the balloon when it was tested for inflation.The investigation could not confirm the circumstances that led to this pin-hole, but it 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: 8848532
• Report Number: 2032493-2019-00184
• Device Sequence Number: 2548871
• Product Code: MJN
• UDI-Device Identifier: 00842636020546
• UDI-Public: (01)00842636020546(11)180716(17)210630(10)18071654H
• Combination Product (Y/N): N
• Initial Reporter Country: BO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2019

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: 06/30/2021
• Device Model Number: BC0415C
• Device Catalogue Number: BC0415C
• Device Lot Number: 18071654H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 07/05/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 82