MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER C OCCLUSION BALLOON (4X10 MM); VASCULAR CLAMP

Model Number	BC0410C-ID
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2020
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 received by the manufacturer for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that after inflation in the patient, the balloon deflation was too slow.The device was removed and replaced to complete the procedure.There was no reported patient injury or additional intervention.
Additional Manufacturer Narrative
The balloon catheter was returned for evaluation.Visual inspection of the device revealed multiple segments of crushes and kinks.The damage identified on the device would negatively impact deflation time as described in the complaint.It is unknown when this damage occurred and the conditions or circumstances that led to the damage could not be determined, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: SCEPTER C OCCLUSION BALLOON (4X10 MM)
• Common Device Name: VASCULAR CLAMP
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10435237
• Report Number: 2032493-2020-00215
• Device Sequence Number: 2963465
• Product Code: MJN
• UDI-Device Identifier: 00842636020539
• UDI-Public: (01)00842636020539(11)181016(17)210930(10)181016546
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 07/21/2020

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: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: BC0410C-ID
• Device Catalogue Number: BC0410C
• Device Lot Number: 181016546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 55