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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during the procedure subject catheter was noted to have a hole in the sidewall.Issue was noticed when guidewire exited the subject catheter through the side.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No additional information provided.

Event Description

It was reported that during the procedure subject catheter was noted to have a hole in the sidewall.Issue was noticed when guidewire exited the subject catheter through the side.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No additional information provided.Update: the subject catheter was returned for analysis on (b)(6) 2020 and the catheter was examined and it was discovered that the reported event of catheter shaft hole/perforation was not confirmed; therefore, the event no longer meets the requirement of the reportable event for the device in question.The reportability changed from reportable to non-reportable as a reportability awareness date (b)(6) 2020.The reported event was not related to a serious public health threat, patient death, unanticipated or anticipated serious injury to the patient.

Manufacturer Narrative

The device was returned, and the reported lot number was confirmed from the hub of the device.During visual inspection, the subject catheter shaft was noted to crushed, kinked/bent and the catheter tip was damaged.The subject catheter hub was intact.During functional inspection, the subject catheter was flushed no leak was identified.A 0.0158" patency mandrel was advanced through the microcatheter without any issue.The reported defect was not confirmed during analysis; however, deformation was noted to the device.Due to the automated mes 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.It can be presumed that the catheter was damaged during the procedure as force may have been applied during removal from the packaging.Because this defect appears to be associated with handling of the product or portion of the product during the procedure/upon removal of the product from the packaging/preparation of the product prior to use, a probable cause of handling damage will be assigned to the as analyzed defect 'catheter shaft flat/crushed' and 'catheter kinked/bent' & 'catheter tip damaged'.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• 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
• MDR Report Key: 10519107
• MDR Text Key: 208821068
• Report Number: 3008881809-2020-00258
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04546540688217
• UDI-Public: 04546540688217
• Combination Product (y/n): N
• PMA/PMN Number: K013789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2021
• Device Model Number: M0031681890
• Device Catalogue Number: M0031681890
• Device Lot Number: 21517536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE (UNKNOWN)