MAUDE Adverse Event Report: SOFIA FLOW PLUS 6F; PERCUTANEOUS CATHETER

Model Number	DA6125ST
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance's 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 returned to the manufacturer for analysis.The investigation is currently underway.
Event or Problem Description
It was reported that during treatment for a carotid t occlusion, a sofia catheter felt jammed in a catheter when retracted.On a follow-up angiographic run, a distal marker was noted in the internal carotid artery.On inspection, the tip of the sofia was observed to have been detached.The tip of the sofia was retrieved with a stent triever.There was no reported harm to the patient.
Additional Manufacturer Narrative
Device ealuation: the physical evaluation of the returned catheter found the tip to be separated from the device with liner material still attached to the marker band and the distal end to be crushed and flattened with protruding coils.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.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.".

• Brand Name: SOFIA FLOW PLUS 6F
• Common Device Name: PERCUTANEOUS CATHETER
• MDR Report Key: 12105141
• Report Number: 2032493-2021-00269
• Device Sequence Number: 19846677
• Product Code: DQO
• UDI-Device Identifier: 00812636020426
• UDI-Public: (01)00812636020426(11)191212(17)221130(10)191212587
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: DA6125ST
• Device Catalogue Number: DA6125ST
• Device Lot Number: 191212587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 07/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR