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 03/11/2024

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 physician felt resistance while inserting the subject catheter into the patient anatomy with elongated vessels.Resistance was encountered at the curves.While withdrawing, the subject catheter was broken and the broken segment was connected by a thin wire.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• 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: 19023218
• MDR Text Key: 339155835
• Report Number: 3008881809-2024-00142
• 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
• Report Date: 04/02/2024

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: 24215108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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