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

Catalog Number M0031681890

Device Problem Material Puncture/Hole (1504)

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

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

It was reported that during a posterior communicating artery (pcoma) aneurysm case, subject microcatheter was used to deliver a stent.While doing so, the stent got stuck inside the subject microcatheter and physician tried adjusting and retrieving the stent but failed.After withdrawal of stent and subject microcatheter together, physician found that the stent delivery wire had protruded from the shaft of subject microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection was performed on the returned sample, and it was observed that the stent was returned within the subject microcatheter shaft.The stent was not protruding from the microcatheter when returned.The microcatheter shaft had a hole 147.5cm from the proximal of the hub and the catheter shaft was found to be stretched.The subject microcatheter tip and hub was intact.From the image attached to the product inquiry (pi) by the operator it appeared to be the stent was protruding from the catheter shaft.Functional testing revealed that the concurrent stent delivery wire (sdw) ((b)(4)) could not be advanced, therefore the sdw was retracted.The stent was seen in the subject microcatheter hub when the sdw was retracted.The subject microcatheter shaft was flushed and water exited the hole in the shaft.The microcatheter was flushed and patency mandrel was advanced without issue.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.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.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, the device confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The subject microcatheter shaft was found to be stretched and a hole was identified.The image attached to the pi appeared to be the stent protruding from the catheter shaft.The damage identified in close proximity to the hole in the shaft indicated resistance was encountered.When the stent became stuck during the procedure an attempt to adjust the stent was made several times which may have caused the stent to protrude though the subject microcatheter shaft.The stent may have become stuck due to some procedural factors during use.The issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and anatomical factors during use, but the product performance was limited.Therefore, the as reported codes catheter shaft has hole/perforation and catheter shaft friction as well as the as analyzed codes catheter shaft stretched, catheter shaft has hole/perforation and catheter shaft friction will be assigned procedural factors.

Event Description

It was reported that during a posterior communicating artery (pcoma) aneurysm case, subject microcatheter was used to deliver a stent.While doing so, the stent got stuck inside the subject microcatheter and physician tried adjusting and retrieving the stent but failed.After withdrawal of stent and subject microcatheter together, physician found that the stent delivery wire had protruded from the shaft of subject microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• 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: 18341542
• MDR Text Key: 331057994
• Report Number: 3008881809-2023-00587
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0031681890
• Device Lot Number: 23960295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2022
• 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: NEUROFORM ATLAS STENT (STRYKER).; SYNCHRO2 GUIDEWIRE (STRYKER).
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Race: Asian