MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 7 .068IN ID X 132CM - CE; CATHETER, THROMBUS RETRIEVER

Catalog Number IC068132A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2023

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 subject catheter was kinked and then broke off.The broken subject catheter was then only hanging at one place.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No further information is available.

Event Description

It was reported that during the procedure, the subject catheter was kinked and then broke off.The broken subject catheter was then only hanging at one place.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No further information is available.

Manufacturer Narrative

Section b1 adverse event/product problem - corrected - no product problem.Section h1 type of reportable event - corrected - no malfunction.Due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the catheter was seen to be kinked.The catheter was seen to be fractured at 25cm from the catheter hub.There were no damages noted to the catheter hub or tip.There were no signs of use of device during use.Functional inspection, visual defect confirmed.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 catheter broken/fractured during use was not confirmed during analysis as the device broke during preparation and also there were no signs of use of the device during procedure.The reported event catheter shaft kinked/bent was confirmed during analysis.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 there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient.The patient¿s anatomy was moderately tortuous.It is possible that the catheter shaft kinked and broke during preparation of the device.An assignable cause of ¿handling damage¿ will be assigned to the as reported and as analyzed ¿catheter shaft kinked/bent¿ as well as the as analyzed ¿catheter shaft broken/fractured during preparation¿, 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.An assignable cause of 'not confirmed' was assigned to the as reported ¿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.

• Brand Name: AXS CATALYST 7 .068IN ID X 132CM - CE
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 18367029
• MDR Text Key: 331068074
• Report Number: 3008881809-2023-00592
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K183464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

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 Number: IC068132A
• Device Lot Number: 24215117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1