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

Model Number	DA6131ST
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/21/2021
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 investigation found the device with a crushed/flattened distal end with broken coils protruding through the jacket 2-11cm from the distal tip and 15-27cm from the distal tip, which are consistent with the customer provided images.Furthermore, kinks were found 14.2cm from the strain relief and 16.1cm from the strain relief.This type of failure is usually seen when the catheter is withdrawn under vacuum through an rhv which is not fully opened.The physical evaluation of the device could not identify the conditions or circumstances that led to the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.
Event or Problem Description
It was reported that a male patient with a left m1 thromboembolic occlusion was treated by endovascularly.An 8f guide catheter was placed in the moderately elongated left cervical ica that had shown atherosclerotic wall changes on the initial ct.The proximal surface of the clot was easily reached with the sofia direct aspiration, however was not sufficient.The clot could be passed with a microcatheter, wire and stent retriever.Standard retrieval under continuous aspiration on the sofia dislodged the clot, however, it was not possible to fully retrieve the stent into the sofia.During the attempts to retrieve, intense axial load was transmitted to the sofia resulting in resistance during advancement and retraction attempts and the device becoming damaged.The solution was that the thrombx was dismantled, its introduction wire cut outside the patient, the proximal basket and all catheters were removed.The introducer wire was then used to deliver a new microcatheter and a different intermediate catheter which allow to retrieve the distal basket together with the clot, resulting in a tici 3 recanalization.The cervical ica showed a dissection in a location that was exposed to the damaged sofia making it possible, but not certain that the dissection was induced by the broken braiding of the sofia.The dissection was successfully stented with an acandis acero stent.The patient was reported to be fine.

• Brand Name: SOFIA FLOW PLUS 6F
• Common Device Name: PERCUTANEOUS CATHETER
• MDR Report Key: 12104381
• Report Number: 2032493-2021-00268
• Device Sequence Number: 4199377
• Product Code: DQO
• UDI-Device Identifier: 00812636020846
• UDI-Public: (01)00812636020846(11)200526(17)230430(10)2005265A9
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: 04/30/2023
• Device Model Number: DA6131ST
• Device Catalogue Number: DA6131ST
• Device Lot Number: 2005265A9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 07/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2020
• 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