MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY FLOWGATE2 8F X 95CM; CATHETER, PERCUTANEOUS

Model Number 90495

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)

Patient Problems Cervical Changes (1773); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

This is 2 of 2 reports for second mdr report regarding the balloon guide catheter device.The subject device is unavailable to manufacturer.

Event Description

The study facility initially reported that the patient presented with a clot located in the left middle cerebral artery (mca) m1 segment.Pre procure, the patient neurological assessment showed a thrombolysis in cerebral infarction (tici) of 0, a national institute of health stroke scale (nihss) of 13, and mrs (modified rankin score) of 0.Patient past history included hypertension (htn).The subject device balloon guide catheter was used during the study procedure.It was reported that the carotid dissectioniatrogenic occurred during study procedure (dissection since bulgar segment to intrapetrous tract).Therefore, the medical intervention was performed with double stenting in response to the patient¿s dissection.On the 30 day follow up, the patient neurological assessment showed mrs (modified rankin score) of 2.The patient has claimed mild cervical pain.The anatomy was severity tortuous with kinking of ica (internal carotid artery).Received additional information on 09-april-2021 indicated that the dissection could be caused by the subject balloon guide catheter but there was no any issue encountered during the use of the subject balloon guide catheter except a minor resistance in the manual use of it.

Manufacturer Narrative

Section b1 adverse event: corrected: no adverse event.Section b2: outcomes attributed to ae: corrected: no other serious (important medical.Events) / no required intervention to prevent permanent impairment/damage (devices).Section h1: type of reportable event: corrected: no serious injury.The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.As per the available information, the anatomy was severely tortuous with kinking of ica.The device was not returned.It is probable that the reported friction was caused by the tortuosity of the patients anatomy.An assignable cause of procedural factors will be assigned to the reported nv - balloon or balloon catheter friction, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.This is 2 of 2 reports regarding the balloon guide catheter device.

Event Description

The study facility initially reported that the patient presented with a clot located in the left middle cerebral artery (mca) m1 segment.Pre procure, the patient neurological assessment showed a thrombolysis in cerebral infarction (tici) of 0, a national institute of health stroke scale (nihss) of 13, and mrs (modified rankin score) of 0.Patient past history included hypertension (htn).The subject device balloon guide catheter was used during the study procedure.It was reported that the carotid dissectioniatrogenic occurred during study procedure (dissection since bulgar segment to intrapetrous tract).Therefore, the medical intervention was performed with double stenting in response to the patient¿s dissection.On the 30 day follow up, the patient neurological assessment showed mrs (modified rankin score) of 2.The patient has claimed mild cervical pain.The anatomy was severity tortuous with kinking of ica (internal carotid artery).Received additional information on 09-april-2021 indicated that the dissection could be caused by the subject balloon guide catheter but there was no any issue encountered during the use of the subject balloon guide catheter except a minor resistance in the manual use of it.Update information: based on additional information received on 26-april-2021 from the medical safety clarified that the patient vessel dissection was not related to the subject flowgate balloon device.Therefore, this event does not meet reporting criteria anymore and the reportability will be changed from reportable to non-reportable with a new awareness date of 26-april-2021.

• Brand Name: FLOWGATE2 8F X 95CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 11698020
• MDR Text Key: 246467920
• Report Number: 3012931345-2021-00066
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00815742004953
• UDI-Public: 00815742004953
• Combination Product (y/n): N
• PMA/PMN Number: K153729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2022
• Device Model Number: 90495
• Device Catalogue Number: 90495
• Device Lot Number: 0000041006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AXS CATALYST7 (STRYKER); MEDELA DOMINANT FLEX PUMP (STRYKER); PENUMBRA MICROCATHETER; SYNCHRO 14 GUIDEWIRE (STRYKER); TREVO XP PROVUE RETRIEVER 4X30 (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR