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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 071 CATH 132CM - CE; CATHETER, THROMBUS RETRIEVER
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STRYKER NEUROVASCULAR-CALIF AXS VECTA 071 CATH 132CM - CE; CATHETER, THROMBUS RETRIEVER Back to Search Results
Catalog Number INC-11988-132
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/19/2023
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, physician advanced the subject catheter through a guiding sheath along with the guidewire.The subject catheter would not advance past the ophthalmic region.Physician tried to use a microcatheter, however the subject catheter still would not advance over it.Physician withdrew the microcatheter and tried withdrawing the subject catheter, however it wouldn't budge.The distal tip of the subject catheter had gotten stuck within the guiding sheath.Physician gave a stronger pull and the back of the subject catheter came out, however the braided end of it remained stuck within the guiding sheath and came out as a stretch/tangle of braid.It was confirmed by the customer that the subject catheter was broken within the guide catheter.Physician removed both the subject catheter along with the guiding sheath.There was surgical delay of 10 minutes noted.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
Manufacturer Narrative
Based on the results of the dhr (device history record) review, there is no indication that the device, labelling or packaging failed to meet its specifications when released.During visual inspection, the catheter was jammed inside another catheter and later removed.The catheter tip was found to be intact.The catheter shaft was seen to be broken/fractured 14.5cm from the tip.The inner coil wind was seen to be exposed through the break in the shaft.The catheter shaft was seen to be kinked in multiple places between 22 and 29cm from the catheter tip and by the catheter strain relief.Functional inspection was not carried out due to the damage noted to the device.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 ¿catheter tip broken/fractured during use¿ was not confirmed during analysis.The reported ¿catheter jammed was confirmed during analysis¿.The reported ¿catheter shaft friction¿ and ¿catheter does not track over guidewire¿ could not be duplicated during device analysis; 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 provided by the customer indicated that continuous flush set up and maintained throughout the procedure.No damage was noted to the packaging prior to opening, the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu.The device was returned for analysis and the catheter was jammed inside the another catheter and later removed.The catheter shaft was seen to be kinked in multiple places and broken/fractured 14.5 cm from the catheter tip.The inner coil wind was seen to be exposed through the break and the shaft.The catheter tip was found to be intact.Therefore, the reported ¿catheter tip broken/fractured during use¿ event was not confirmed.An assignable cause of ¿not confirmed¿ will be assigned to the as reported ¿catheter tip broken/fractured during use¿ as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.An assignable cause of ¿procedural factors¿ will be assigned to the as reported and as analyzed ¿catheter jammed¿, ¿catheter shaft friction¿ and ¿catheter does not track over guidewire¿ and as analyzed ¿catheter shaft kinked/bent¿ and ¿catheter shaft broken/fractured during use¿ as these defects are 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.Should any information become available in the future that could impact the current assessment decision, the complaint will be reopened and updated accordingly.
 
Event Description
It was reported that during the procedure, physician advanced the subject catheter through a guiding sheath along with the guidewire.The subject catheter would not advance past the ophthalmic region.Physician tried to use a microcatheter, however the subject catheter still would not advance over it.Physician withdrew the microcatheter and tried withdrawing the subject catheter, however it wouldn't budge.The distal tip of the subject catheter had gotten stuck within the guiding sheath.Physician gave a stronger pull and the back of the subject catheter came out, however the braided end of it remained stuck within the guiding sheath and came out as a stretch/tangle of braid.It was confirmed by the customer that the subject catheter was broken within the guide catheter.Physician removed both the subject catheter along with the guiding sheath.There was surgical delay of 10 minutes noted.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
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Brand Name
AXS VECTA 071 CATH 132CM - CE
Type of Device
CATHETER, THROMBUS RETRIEVER
Manufacturer (Section D)
STRYKER NEUROVASCULAR-CALIF
47900 bayside parkway
fremont CA 94538
Manufacturer (Section G)
STRYKER NEUROVASCULAR-CALIF
47900 bayside parkway
fremont CA 94538
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key17934796
MDR Text Key325946159
Report Number3008853977-2023-00040
Device Sequence Number1
Product Code NRY
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K172167
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 12/22/2023
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 Catalogue NumberINC-11988-132
Device Lot Number17475-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/20/2023
Initial Date FDA Received10/13/2023
Supplement Dates Manufacturer Received12/20/2023
Supplement Dates FDA Received12/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CEREBASE GUIDE SHEATH (JOHNSON & JOHNSON).; GUIDEWIRE (UNKNOWN).; REACT CATHETER (MEDTRONIC).; REBAR 18 MICROCATHETER (MEDTRONIC).; TREVO STENT RETRIEVER (STRYKER).
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