MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER XC OCCLUSION BALLOON (4X11MM)

Model Number	BC0411XC
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/22/2019
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.The returned device was inspected, and the balloon was found to be missing along with a length of the distal portion of the catheter.The inner (guidwire) lumen seemed to be severed further back than the outer (inflation) lumen.The outer lumen was measured at 126cm, and after separating the two lumens, the inner lumen was measured at 115.5cm.The outer inflation lumen was also missing its coil in the distal 0.6cm.The inner guidwire lumen was stretched out and its coil was protruding at its distal end with onyx stuck to it.The investigation confirmed the reported complaint that the catheter was separated during the procedure.The distal 24cm of the outer lumen and 34.5cm of the inner lumen were missing.The signs of stretching in the catheter, and the stretched, damaged, and missing coil likely point to the catheter being pulled out by force after it was stuck inside the onyx.
Event or Problem Description
It was reported that during treatment of a fistula in the right posterior fossa, the onyx liquid embolic was delivered and the tip of the scepter xc balloon became stuck in the onyx.The scepter broke in the middle of the catheter in the aorta during the attempt to remove the scepter.The distal half of the scepter remained in the patient.Aspirin 325 mg was prescribed for the patient (duration unknown).No additional intervention was performed.

• Brand Name: SCEPTER XC OCCLUSION BALLOON (4X11MM)
• Common Device Name: BALLOON
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9360110
• Report Number: 2032493-2019-00274
• Device Sequence Number: 2973490
• Product Code: MJN
• UDI-Device Identifier: 00842636020591
• UDI-Public: (01)00842636020591(11)190309(17)220228(10)190309553
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K110741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2019

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: BC0411XC
• Device Catalogue Number: BC0411XC
• Device Lot Number: 190309553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/21/2019
• 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: Disability
• Patient Age: 68 YR