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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
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STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) Back to Search Results
Catalog Number UNK_NEU
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2020
Event Type  Injury  
Manufacturer Narrative
The subject device is unavailable to manufacturer.
 
Event Description
It was reported that the subject aspiration pump device along with other devices were used to remove a clot from the left m2 -mca (middle cerebral artery).Pre procedure, the patient¿s thrombolysis in cerebral infarction score (tici) of 0.During procedure, a new ent (embolization to the new territory) occurred from right mc (middle cerebral) m2 to right aca (anterior cerebral artery ) a3, therefore, the second pass was performed to treat the ent and there were no adverse events or complications during this pass.The procedure was completed with tici of 3 and health stroke scale (nihss) score of 4.No other information was provided.
 
Manufacturer Narrative
Section b1 adverse event: corrected: no adverse event section b2: outcomes attributed to ae: corrected: no other serious (important medical events or required intervention to prevent permanent impairment/damage (devices), section b5 - executive summary: update section h1: type of reportable event: corrected: no serious injury f10 / h6 device code grid - corrected.F10 / h6 clinical signs code grid - corrected.F10 / h6 health impact code grid - corrected.Based on additional information received on (b)(6) 2021 that the site has definitely confirmed that the ent was entered by mistake.The pass for ent was deleted and the location of proximal face of clot on diagnostic angiogram was m2 only.Additionally, there was no adverse events/complications during this pass and no allegation of device malfunction reported.Although the serial number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.As per medela ag, 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.Based on additional information available, the medela dominant flex pump is unrelated to the reported event, an assignable cause of not confirmed will be assigned to this complaint.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
 
Event Description
It was reported that the subject aspiration pump device along with other devices were used to remove a clot from the left m2 -mca (middle cerebral artery).Pre procedure, the patient¿s thrombolysis in cerebral infarction score (tici) of 0.During procedure, a new ent (embolization to the new territory) occurred from right mc (middle cerebral) m2 to right aca (anterior cerebral artery ) a3, therefore, the second pass was performed to treat the ent and there were no adverse events or complications during this pass.The procedure was completed with tici of 3 and health stroke scale (nihss) score of 4.No other information was provided.Update information: based on additional information received on (b)(6)2021 that the site has definitely confirmed that the ent was entered by mistake.The pass for ent was deleted and the location of proximal face of clot on diagnostic angiogram was m2 only.Additionally, there was no adverse events/complications during this pass and no allegation of device malfunction reported.
 
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Brand Name
UNKNOWN_NEUROVASCULAR_PRODUCT
Type of Device
PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI  NA
MDR Report Key10752735
MDR Text Key213645368
Report Number3002807523-2020-00002
Device Sequence Number1
Product Code BTA
Combination Product (y/n)N
PMA/PMN Number
P170329
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_NEU
Was Device Available for Evaluation? No
Date Manufacturer Received03/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AXS CATALYST 7 DISTAL ACCESS CATHETER (STRYKER).; AXS INFINITY LONG SHEATH CATHETER (STRYKER).; SYNCHRO 2 GUIDEWIRE (STRYKER).; TREVO PRO 14 (STRYKER).; TREVO XP PROVUE RETRIEVER (STRYKER).; AXS CATALYST 7 DISTAL ACCESS CATHETER (STRYKER); AXS INFINITY LONG SHEATH CATHETER (STRYKER); SYNCHRO 2 GUIDEWIRE (STRYKER); TREVO PRO 14 (STRYKER); TREVO XP PROVUE RETRIEVER (STRYKER)
Patient Outcome(s) Other; Required Intervention;
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