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

Model Number	ISC5115ST-MVI
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2021
Type of Reportable Event	Malfunction
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 physical evaluation of the returned sofia found the tip to be separated from the device at the proximal edge of the marker band along with unraveled coil wire.The separated tip is consistent with the information provided in the alleged product issue.The damage to the catheter is consistent with increased friction and could be associated with navigating the sofia catheter.There was no evidence of delamination of the inner liner underneath the marker band.Also, the coil underneath the marker band was still intact.The distal tip of the catheter broke off due to high tensile force.The average force required to break the reinforcement wire is 3.59lbs.The physical evaluation of the device alone could not determine the circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.The sofia ifu warnings state "do not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined.".
Event or Problem Description
It was reported that during the treatment of an aneurysm of the anterior communicating artery, the anatomy was very tortuous and it was decided to exchange a sofia ex catheter for a longer one.While removing the sofia ex over the exchange wire, the physician noticed the tip of the sofia ex was damaged and missing its distal marker band.As he manipulated the wire to introduce the new catheter, they noticed the distal marker was outside of the sheath and wrapped around the exchange wire.There was no intervention or patient injury.

• 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: 11735558
• Report Number: 2032493-2021-00160
• Device Sequence Number: 14508255
• Product Code: DQY
• UDI-Device Identifier: 00842429101582
• UDI-Public: (01)00842429101582(11)190129(17)211231(10)19012914EM
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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: 12/31/2021
• Device Model Number: ISC5115ST-MVI
• Device Catalogue Number: ISC5115ST
• Device Lot Number: 19012914EM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2021
• Initial Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1