MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 45 150CM; CATHETER, PERCUTANEOUS

Model Number M0031681900

Device Problem Material Puncture/Hole (1504)

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

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection indicated that the stent was returned within the catheter shaft.The catheter shaft was intact.The stent was protruding from the distal catheter shaft.The stent strut had pierced through the catheter distal shaft.The catheter hub was intact.There was blood present on the removed stent.During functional inspection an attempt to advance the delivery wire was made but it could not be advanced in the catheter shaft due to the strut of the stent protruding from the distal shaft.The catheter distal shaft was cut to remove the stent.There was a hole in the catheter shaft when the stent was removed.The uncut part of the catheter shaft was flushed and a patency mandrel was advanced through the microcatheter without any resistance felt.The reported event is covered in the device direction 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.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use and the device was confirmed to be in good condition during preparation/prior to use on the patient.In the case of this complaint it is most likely that the issue occurred due to procedural or anatomical factors during the procedure.The catheter may have become damaged due to the force applied when resistance was felt advancing/retracting the atlas stent.Based on analysis and the event description the as reported can be confirmed.The catheter shaft friction as well as the catheter shaft has hole/perforation will be assigned procedural factors as this complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

Event Description

Analysis of the returned device found that the subject catheter shaft has hole/perforation.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 45 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: 11822786
• MDR Text Key: 251907358
• Report Number: 3008881809-2021-00200
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04546540688224
• UDI-Public: 04546540688224
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K042568
• 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: 05/13/2021

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 Expiration Date: 01/07/2022
• Device Model Number: M0031681900
• Device Catalogue Number: M0031681900
• Device Lot Number: 22048017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2020
• 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
• Patient Age: 71 YR
• Patient Weight: 60