MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 7 .068IN ID X 115CM - CE; CATHETER, THROMBUS RETRIEVER

Catalog Number IC068115A

Device Problem Fracture (1260)

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

Event Date 03/23/2023

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, when using the subject catheter to do radiography, the proximal of the subject catheter was fractured.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Event Description

It was reported that during the procedure, when using the subject catheter to do radiography, the proximal of the subject catheter was fractured.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H4 manufacturing date : added.H3 device evaluated by mfg : updated.H3 summary attached : updated.D4 expiration date - added.D10 product available to stryker : updated.D10 returned to manufacturer on : updated.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 shaft was found to be broken/fractured 6cm from the proximal end of the catheter.The catheter shaft was found to be kinked/bent in multiply areas.During functional inspection, the catheter shaft broken/fractured during use functional test was not applicable as the defect was confirmed during visual inspection.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 complaint was confirmed based on 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 the device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The patient's anatomy was moderately tortuous.During the analysis the catheter shaft was seen to be broken/fractured.The catheter shaft was found to be kinked/bent in multiply areas.An assignable cause of procedural factors will be assigned to as reported and as analyzed ¿catheter shaft broken/fractured during use¿ as well as the as analyzed ¿catheter shaft kinked/bent¿, 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 factors during use.

• Brand Name: AXS CATALYST 7 .068IN ID X 115CM - 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: 16801600
• MDR Text Key: 313952684
• Report Number: 3008881809-2023-00203
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/25/2023

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 Number: IC068115A
• Device Lot Number: 23942920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2022
• 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
• Treatment: EXCELSIOR SL 10 MICROCATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: Asian