MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS INFINITY LS PLUS .091IN ID X 80CM-CE; CATHETER, PERCUTANEOUS

Catalog Number INC-11987-80

Device Problem Peeled/Delaminated (1454)

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

Event Date 09/18/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the results of the dhr (device history record ) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection there was a dilator jammed inside the subject long sheath catheter.There was a detached polytetrafluoroethylene (ptfe) inner lining present at the proximal end of the dilator.The dilator catheter was removed, and the detached ptfe sample was collected.The subject long sheath catheter shaft was seen to be kinked at 21 and 57cm from the tip.The hub and the catheter tip were found to be intact.Functional testing was not performed.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 of a product coating issue was confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The subject long sheath catheter was returned with a dilator jammed inside it and there was a detached ptfe inner lining present at the proximal end of the dilator.The dilator was removed, and ptfe sample was collected.During the analysis, the subject long sheath catheter shaft was seen to be kinked.The hub and the catheter tip were found to be intact.As per the additional information, the problem with subject long sheath catheter was discovered during the preparation phase and the device was never used.But before this problem with subject long sheath catheter was observed, a nurse had already inserted the dilator in preparation.An assignable cause of handling damage was assigned to the as reported ¿product coating issue¿ as well as the analyzed damage of the subject long sheath ¿catheter ptfe inner lining peeling¿ and ¿catheter shaft kinked/bent¿ as this complaint appears to be associated with handling of the product or portion of the product .

Event Description

The device was returned for analysis and the investigation of the device revealed that the catheter (subject device) ptfe coating was peeling.The procedure was completed successfully with no clinical consequences were reported to the patient due to this event.

• Brand Name: AXS INFINITY LS PLUS .091IN ID X 80CM-CE
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 18540910
• MDR Text Key: 333198923
• Report Number: 3008853977-2024-00005
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K152876
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INC-11987-80
• Device Lot Number: 21080-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2023
• 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