MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 074 CATH 132CM - US; CATHETER, THROMBUS RETRIEVER

Model Number	INC-11597-132
Medical Device Problem Codes	Fracture (1260); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject catheter broke into two halves when the technician went to prepare it for a procedure.Upon request for additional information, a picture was received on 25-feb-2022 from the customer which shows procedural fluids on the subject catheter hub and on the hoop indicating that the subject catheter might have broken during use in the procedure.It is unclear whether reported issue occurred during preparation or during procedure.No additional information is available.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
B5 - executive summary : updated.H3 summary attached - updated.H3 device evaluated by mfg ¿updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the catheter shaft was seen to be broken 14 cm from the catheter hub.The catheter shaft was seen to be kinked 25cm from the hub.There were no signs of procedural fluid observed inside the catheter.Functional inspection: not required as the defects were confirmed during analysis.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 device was returned for analysis and the catheter shaft was seen to be broken and kinked.There were no signs of procedural fluid observed inside the catheter.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to preparation of the device, there were no anomalies noted to the device after removal from the packaging or prior to preparation and the device was prepared as per the dfu.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 factors during use.Therefore, an assignable cause of procedural factors will assigned to as reported/as analyzed 'catheter shaft kinked/bent'.Because this complaint appears to be associated with handling of the product or portion of the product , a probable cause of handling damage was assigned to as analyzed 'catheter shaft broken/fractured during preparation'.An assignable cause of 'not confirmed' was assigned to the ar defect 'catheter shaft 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.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 or Problem Description
It was reported that the subject catheter broke into two halves when the technician went to prepare it for a procedure.Upon request for additional information, a picture was received on 25-feb-2022 from the customer which shows procedural fluids on the subject catheter hub and on the hoop indicating that the subject catheter might have broken during use in the procedure.It is unclear whether reported issue occurred during preparation or during procedure.No additional information is available.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.Additional information received on 28-mar-2022, clarified that the subject catheter was not used in a procedure they had it prepped and during preparation it broke.The fluid on it was from the table.
Additional Manufacturer Narrative
B1: adverse event/product problem ¿ corrected - no ¿product problem¿ h1: type of reportable event ¿ corrected - no ¿malfunction¿ f10 / h6 device code grid - medical device problem code ¿ added ¿deformation due to compressive stress¿ h6 results code grid - investigation findings ¿ corrected to ¿deformation problem¿ and ¿fracture problem¿ h6 conclusion code grid - investigation conclusions ¿ corrected to ¿unintended use error caused or contributed to event¿ due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection confirmed the catheter shaft was seen to be broken.The catheter shaft was seen to be kinked.There were no signs of procedural fluid observed inside the catheter.Functional inspection was not required as the defects were confirmed during analysis.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 will be confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was returned for analysis and the catheter shaft was seen to be broken and kinked.There were no signs of procedural fluid observed inside the catheter.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to preparation of the device, there were no anomalies noted to the device after removal from the packaging or prior to preparation and the device was prepared as per the dfu.Because this complaint appears to be associated with handling of the product or portion of the product upon removal of the product from the packaging / preparation of the product prior to use, a probable cause of handling damage was assigned to the as reported event and as analyzed code, 'catheter shaft broken/fractured during preparation' and catheter shaft kinked bent.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 or Problem Description
It was reported that the subject catheter broke into two halves when the technician went to prepare it for a procedure.Upon request for additional information, a picture was received on 25-feb-2022 from the customer which shows procedural fluids on the subject catheter hub and on the hoop indicating that the subject catheter might have broken during use in the procedure.It is unclear whether reported issue occurred during preparation or during procedure.No additional information is available.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.Additional information received on 28-mar-2022, clarified that the subject catheter was not used in a procedure they had it prepped and during preparation it broke.The fluid on it was from the table.

• Brand Name: AXS VECTA 074 CATH 132CM - US
• Common Device Name: 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 Key: 13895382
• Report Number: 3008853977-2022-00015
• Device Sequence Number: 11733186
• Product Code: NRY
• UDI-Device Identifier: 07613327459265
• UDI-Public: 07613327459265
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K172167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2022
• Device Model Number: INC-11597-132
• Device Catalogue Number: INC-11597-132
• Device Lot Number: 14622-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 03/31/2022; 12/05/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/19/2022; 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown