MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 STRAIGHT 2 TIP 150CM; CATHETER, PERCUTANEOUS

Model Number M0031681890

Device Problem Material Puncture/Hole (1504)

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

Event Date 08/31/2022

Event Type  malfunction  

Manufacturer Narrative

Due to the automated manufacturing execution system there are controls in the manufacturing process to ensure the product met specifications upon release.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 device was returned and the lot number was confirmed with the packaging label returned with the device.During visual inspection, the subject catheter was found kinked/bent and with a hole a few centimeters from the hub.The catheter tip was found flat/crushed and the device hub was intact.Functional inspection was not confirmed as visual inspection results proved sufficient.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use an there was no damage noted to the packaging prior to opening the packaging.Also additional information provided indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient.The reported defect was confirmed based on analysis of the device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was returned for analysis and its shaft was found to be badly kinked with a hole and its tip flattened which would not have left the manufacturing process due to the controls in place.The as reported event of catheter shaft kinked/bent as well as the as analyzed events of catheter shaft kinked/bent, catheter tip flat/crushed and catheter shaft has hole/perforation will be assigned an assignable cause of handling damage 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.

Event Description

Analysis of the returned device revealed that the subject catheter shaft had a hole.No clinical consequences were reported to the patient due to this event and the procedure was completed successfully.

• Brand Name: EXCELSIOR SL-10 STRAIGHT 2 TIP 150CM
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 15796528
• MDR Text Key: 307327118
• Report Number: 3008881809-2022-00573
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04546540688217
• UDI-Public: 04546540688217
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K013789
• 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: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2023
• Device Model Number: M0031681890
• Device Catalogue Number: M0031681890
• Device Lot Number: 23388884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2021
• 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