MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER XC OCCLUSION BALLOON (4X11 MM); VASCULAR CLAMP

Model Number	BC0411XC-ID
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paresis (1998); Perforation of Vessels (2135)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
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.Visual investigation of the returned device found multiple kinks 66.7cm from the strain relief tip.Inspection of the balloon did not find any atypical coating or damage.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 forces over specification.It is unknown when the kinks occurred.This device was used during the same procedure as the device referenced in mfr.Report # 2032493-2020-00090.
Event or Problem Description
It was reported that treatment was performed on a left, bi-lobed carotid t aneurysm using a kissing balloon technique with a scepter xc balloon and another company's balloon.The trackability of the scepter balloon over the traxcess guide wire around vessel curves was poor and there was a lot of friction.During manipulation of the devices, a distal vessel perforation occurred in the pericallosal artery.Bleeding was controlled by an inflation with the other company's balloon.The patient still has a slight hemiparesis that is improving and a weakness of "a branch" of the mouth.The patient is recovering slowly and plans were being made to discharge the patient from the hospital.
Additional Manufacturer Narrative
One ct 3d reconstruction image and one ct image of the brain was provided and reviewed by mv's product safety physician.The ct image demonstrates what appears to be accumulation of blood in a manner that is consistent with the pericallosal artery perforation described in the complaint.The ct 3d vessel reconstructed image shows a bi-lobed aneurysm at the carotid t.Both of these images are consistent with the complaint.This device was used during the same procedure as the device referenced in mfr.Report # 2032493-2020-00090.

• Brand Name: SCEPTER XC OCCLUSION BALLOON (4X11 MM)
• Common Device Name: VASCULAR CLAMP
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9925460
• Report Number: 2032493-2020-00089
• Device Sequence Number: 19657435
• Product Code: MJN
• UDI-Device Identifier: 00842636020591
• UDI-Public: (01)00842636020591(11)191107(17)221031(10)19110752U
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: BC0411XC-ID
• Device Catalogue Number: BC0411XC
• Device Lot Number: 19110752U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR