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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 6 .060IN ID X 132CM - CE; CATHETER, PERCUTANEOUS
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STRYKER NEUROVASCULAR CORK AXS CATALYST 6 .060IN ID X 132CM - CE; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number M003IC060132A0
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Paralysis (1997); Dysphasia (2195)
Event Date 02/16/2021
Event Type  Injury  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported during procedure to perform acute blood circulation recanalization therapy for m2 obstruction, a microcatheter and a retriever was guided using guidewire.It was reported that the patient¿s anatomy was very tortuous which caused difficulty in advancing the devices to the target site.Stent retriever was able to cross the obstruction site and was deployed.Accompanying microcatheter was removed and subject distal access catheter was placed along the retriever wire.Physician confirmed bleeding from the lesion site via imaging immediately after induction, integration with the stent retriever and removal from the body.A balloon catheter was expanded and waited for several minutes under blood collection blockage, but hemostasis was not obtained.The physician then guided another microcatheter and vascular embolization was performed using 3 coils and nbca (n-butyl cyanoacrylate).After the procedure patient was noted to have paralysis and aphasia.Preoperative condition of the patient is unknown and it is unable to confirm whether the symptom have worsened.No further information was provided.
 
Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 additional information, device was prepared for use as per the directions for use, and there was no damage noted to the packaging prior to opening the packaging, the device confirmed to be in good condition during preparation/prior to use on the patient, continuous flush set up and maintained throughout the clinical procedure, and resistance was reported during thrombectomy within vessel, and patient's anatomy was very tortuous.While the reported patient harms are anticipated in nature and are listed as so in the dfu, it cannot be definitively determined if the reported device difficulty engaging target vessel, caused or contributed to the adverse events.An assignable cause of undeterminable will be assigned to the reported device difficulty engaging target vessel.A review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.Furthermore, an assignable cause of anticipated procedural complications will be assigned to the as reported, patient hemorrhage/ blood loss with sequelae and patient neurological deficit.H3 other text : the device is not available to the manufacturer.
 
Event Description
It was reported during procedure to perform acute blood circulation recanalization therapy for m2 obstruction, a microcatheter and a retriever was guided using guidewire.It was reported that the patient¿s anatomy was very tortuous which caused difficulty in advancing the devices to the target site.Stent retriever was able to cross the obstruction site and was deployed.Accompanying microcatheter was removed and subject distal access catheter was placed along the retriever wire.Physician confirmed bleeding from the lesion site via imaging immediately after induction, integration with the stent retriever and removal from the body.A balloon catheter was expanded and waited for several minutes under blood collection blockage, but hemostasis was not obtained.The physician then guided another microcatheter and vascular embolization was performed using 3 coils and nbca (n-butyl cyanoacrylate).After the procedure patient was noted to have paralysis and aphasia.Preoperative condition of the patient is unknown and it is unable to confirm whether the symptom have worsened.No further information was provided.
 
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Brand Name
AXS CATALYST 6 .060IN ID X 132CM - CE
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI  NA
MDR Report Key11457747
MDR Text Key239061516
Report Number3008881809-2021-00119
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K183463
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/16/2022
Device Catalogue NumberM003IC060132A0
Device Lot Number22342663
Was Device Available for Evaluation? No
Date Manufacturer Received05/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DETACHABLE COIL (UNKNOWN); DETACHABLE COIL (UNKNOWN); DETACHABLE COIL (UNKNOWN); EXCELSIOR SL-10 MICROCATHETER (STRYKER); FLOWGATE 2 BALLOON CATHETER (STRYKER); N-BUTYL CYANOACRYLATE (UNKNOWN); SYNCHRO2 GUIDEWIRE (STRYKER); TREVO NXT STENT RETRIEVER (STRYKER); TREVO TRAK21 MICROCATHETER (STRYKER); DETACHABLE COIL (UNKNOWN); DETACHABLE COIL (UNKNOWN); DETACHABLE COIL (UNKNOWN); EXCELSIOR SL-10 MICROCATHETER (STRYKER); FLOWGATE 2 BALLOON CATHETER (STRYKER); N-BUTYL CYANOACRYLATE (UNKNOWN); SYNCHRO2 GUIDEWIRE (STRYKER); TREVO NXT STENT RETRIEVER (STRYKER); TREVO TRAK21 MICROCATHETER (STRYKER)
Patient Outcome(s) Other; Required Intervention; Disability;
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