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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY FLOWGATE2 8F X 85CM; CATHETER, PERCUTANEOUS
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STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY FLOWGATE2 8F X 85CM; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 90485
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
Event Type  malfunction  
Event Description
It was reported that subject balloon catheter was used during ic (internal carotid artery) neuro-endovascular procedure for cerebral infarction.During preparation subject balloon catheter was inflation and deflation successfully.During procedure while insertion of the subject balloon catheter, resistance was noted into the introducer sheath.The balloon was advanced to the targeted lesion and initially when the balloon was inflated, deflation was not possible.Three-way stopcock was removed to deflate the balloon.The balloon was inflated again, and physician performed the procedure.When physician tried to deflate it but could not.The three-way stopcock was removed in the same way as before, but since deflation was not possible, it was retrieved by rupturing it in the introducer sheath.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
Event Description
It was reported that subject balloon catheter was used during ic (internal carotid artery) neuro-endovascular procedure for cerebral infarction.During preparation subject balloon catheter was inflation and deflation successfully.During procedure while insertion of the subject balloon catheter, resistance was noted into the introducer sheath.The balloon was advanced to the targeted lesion and initially when the balloon was inflated, deflation was not possible.Three-way stopcock was removed to deflate the balloon.The balloon was inflated again, and physician performed the procedure.When physician tried to deflate it but could not.The three-way stopcock was removed in the same way as before, but since deflation was not possible, it was retrieved by rupturing it in the introducer sheath.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the balloon catheter was found to be damaged.The balloon catheter was found to be kinked/bent.The balloon was found to be damaged.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 'balloon catheter damaged' was confirmed during analysis.The reported 'balloon difficult to insert' and 'balloon difficult/unable to deflate during use' could not be confirmed; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received indicated that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition during preparation/prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure and the patient¿s anatomy was described as normal.The peel away sheath was used when inserting the balloon into the introducer sheath.As the device was successfully inflated and deflated during preparation without issue, it is probable that the balloon and balloon catheter were damaged during use causing the reported failure to deflate.It was reported that 'there was resistance during insertion into the sheath.The balloon was then inflated, but deflation was not possible, and the three-way stopcock was removed and deflated.The balloon was inflated again, performed the procedure, and tried to deflate it, but could not.The three-way stopcock was removed in the same way as before, but since deflation was not possible, it was retrieved by rupturing it in the sheath'.It is further reported in the gfe follow-up questions that the balloon was ruptured 'by removing the three-way stopcock'.During inspection in the complaint laboratory the catheter shaft was confirmed to be damaged as well as kinked/bent along its length.The balloon was also noted to be damaged.The balloon could not be inflated/deflated due to the condition of the returned device.The as reported codes as well as the as analyzed codes balloon catheter kinked/bent, balloon catheter damaged and balloon damaged will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.
 
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Brand Name
FLOWGATE2 8F X 85CM
Type of Device
CATHETER, PERCUTANEOUS
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 Key13944608
MDR Text Key288269559
Report Number3012931345-2022-00064
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00815742004854
UDI-Public00815742004854
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K153729
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 06/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/27/2023
Device Model Number90485
Device Catalogue Number90485
Device Lot Number0000066496
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/01/2022
Initial Date FDA Received03/29/2022
Supplement Dates Manufacturer Received05/31/2022
Supplement Dates FDA Received06/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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