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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 SUPPORT PS 215CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE
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STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 SUPPORT PS 215CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE Back to Search Results
Catalog Number SSUP215PRE
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2023
Event Type  malfunction  
Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
 
Event Description
It was reported that during the procedure, the ptfe coating of the subject guidewire was peeled off when the introducer was used.The subject guidewire was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
Manufacturer Narrative
H4 manufacturing date - added d4 expiration date - added there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot 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.The reported event could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer indicated that there was no resistance when the guidewire was taken out of the dispenser hoop, the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the dfu, the guidewire tip was not shaped, the model/inner diameter of the microcatheter used in the procedure was unknown, flush was given inside the microcatheter when the guidewire was inserted, it is unknown whether the torque device was used with the guidewire, and the introducer was used when inserting the guidewire.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to the as reported "guidewire ptfe coating peeling".
 
Event Description
It was reported that during the procedure, the ptfe coating of the subject guidewire was peeled off when the introducer was used.The subject guidewire was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
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Brand Name
SYNCHRO SELECT-14 SUPPORT PS 215CM
Type of Device
GUIDE, WIRE, CATHETER, NEUROVASCULATURE
Manufacturer (Section D)
STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
4870 west 2100 south
salt lake city UT 84120
Manufacturer (Section G)
STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
4870 west 2100 south
salt lake city UT 84120
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key18371558
MDR Text Key331187095
Report Number3012931345-2023-00265
Device Sequence Number1
Product Code MOF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K202522
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSSUP215PRE
Device Lot Number0000238648
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/23/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/27/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MICROCATHETER (UNKNOWN).
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