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 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during the procedure, the microcatheter (subject device) could not be retracted to deploy the stent and the stent could not be advanced and got stuck in the subject microcatheter.The physician withdrew the system from the patient and found the tip of the microcatheter had been perforated by the stent.The physician replaced it with a new microcatheter and continued the procedure without clinical consequences to the patient.

Event Description

It was reported that during the procedure, the microcatheter (subject device) could not be retracted to deploy the stent and the stent could not be advanced and got stuck in the subject microcatheter.The physician withdrew the system from the patient and found the tip of the microcatheter had been perforated by the stent.The physician replaced it with a new microcatheter and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

D4 expiration date - added.D9 product available to stryker- updated.D9 returned to manufacturer on- updated.H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the microcatheter was found to be returned with the stent delivery wire (sdw) from the stent complaint advanced through the microcatheter hub.The microcatheter shaft was seen to be kinked and flat/crushed.The microcatheter shaft was seen to have perforated and the inner coil wind was seen to be exposed by the microcatheter tip.The microcatheter hub was intact.A functional test for the reported catheter shaft friction was performed.The sdw was removed from the microcatheter and the microcatheter was flushed and a 0.0158" patency mandrel was advanced through the catheter with resistance felt in areas of damage.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 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 analyzed.The microcatheter shaft was found to be kinked and flattened which most likely occurred due to some procedural or anatomical factors during use.The catheter distal shaft was found to have a hole.The catheter distal shaft was most likely damaged when force was applied to the sdw trying to advance the stent.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.Also additional information indicated the patients anatomy was very meandering which would have contributed to the event.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, the product performance was limited.The as reported catheter shaft friction, catheter shaft has hole/perforation and device interaction with another device as well as the as analyzed catheter shaft kinked/bent, catheter shaft flat/crushed, catheter shaft has hole/perforation and catheter shaft friction will be assigned procedural factors.

• 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: 16037461
• MDR Text Key: 308243084
• Report Number: 3008881809-2022-00648
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04546540688217
• UDI-Public: 04546540688217
• 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,Followup
• Report Date: 02/27/2023

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: 03/18/2023
• Device Model Number: M0031681890
• Device Catalogue Number: M0031681890
• Device Lot Number: 22810183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2021
• 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
• Treatment: NEUROFORM ATLAS STENT (STRYKER); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Race: Asian