MAUDE Adverse Event Report: MICROVENTION, INC SOFIA-5F EX; PERCUTANEOUS CATHETER

Model Number	ISC5115ST-MVI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 returned to the manufacturer for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during use in the patient, the tip of the catheter detached during retraction into the infinity sheath.An attempt was made to retrieve the tip with a stent retriever, but it was unsuccessful.The tip remains in the patient.There was no reported sequelae.
Additional Manufacturer Narrative
(b5): additional information provided confirmed there was a tight kink in the infinity sheath.During removal of the sofia through the infinity in the ica, the sofia was retracted with force and the sofia tip, including the marker band, sheared off.During the attempts to remove the tip with the stent retriever, the tip was pushed into the middle cerebral artery (mca) and then farther down into the distal segment of the mca with each removal attempt.The physical evaluation of the returned sofia confirmed the missing marker band, a dislodged and unraveled catheter coil, stretched ptfe liner, and a hole in the catheter shaft.The missing marker band and damage noted on the device is consistent with the complaint information provided.The evaluation of the device alone could not identify the circumstances that led to the damages, but the damages are consistent with the application of forces to the device that exceeded specifications.An image of the adjunct stryker infinity sheath taken during the procedure demonstrates the reported kink.This kink would have caused the difficulty withdrawing the sofia and the subsequent damage to the sofia as was found in the investigation.The sofia ifu warnings state, "do not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined." two dsa fluoroscopic images were provided, which demonstrate a small circular, radiopaque object within a cerebral artery, although the exact location could not be determined.The general shape of the radiopaque object is consistent with the distal tip marker band of a sofia catheter.

• Brand Name: SOFIA-5F EX
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 10694063
• Report Number: 2032493-2020-00293
• Device Sequence Number: 16945039
• Product Code: DQY
• UDI-Device Identifier: 00842429101582
• UDI-Public: (01)00842429101582(11)200220(17)230131(10)20022012H
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2023
• Device Model Number: ISC5115ST-MVI
• Device Catalogue Number: ISC5115ST
• Device Lot Number: 20022012H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 10/28/2020
• 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