MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY UNKNOWN_NEUROVASCULAR_PRODUCT; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Catalog Number UNK_NEU

Device Problem Peeled/Delaminated (1454)

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

Event Date 10/31/2023

Event Type  malfunction  

Event Description

The device was returned for analysis and the investigation of the device revealed in the returned catheter ptfe coating from the guidewire was present in the catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

This is report 3 of 4.Although the device history record (dhr) could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The observed event is covered in the device directions for use (dfu).As well, the risk of the observed event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The polytetrafluoroethylene (ptfe) material found within the returned microcatheter is likely to have originated from the subject guidewire which was reported to have been used to guide the microcatheter.It is likely that the guidewire ptfe coating may have been damaged due to backloading of the wire into the supplied introducer or interaction with an under tightened torque device, causing some ptfe material to be introduced into the microcatheter shaft.As there was no allegation of failure against the guidewire, an assignable cause of not confirmed will be assigned to the reported event of the device problem unknown/unclear.An assignable cause of handling damage will be assigned to the analyzed damage of the guidewire ptfe coating peeling, as a review of the available information and the analysis of the returned devices indicates that the issue may have been caused due to handling of the device during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: GUIDE, WIRE, CATHETER, NEUROVASCULATURE
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• 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: 18813876
• MDR Text Key: 337569820
• Report Number: 3012931345-2024-00035
• Device Sequence Number: 1
• Product Code: MOF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K202522
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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: SL-10 CATHETER (STRYKER)
• Patient Race: Asian