MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-27 STD PRE-SHAPED 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M003XT2750910
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the operator placed the subject microcatheter to deploy the stent.When withdrawing the subject microcatheter to deploy the stent, the operator felt friction, he tried several times to adjust by advancing the stent system and subject microcatheter but big friction was still encountered.Finally, the operator withdrew the stent and subject microcatheter out together and found part of the stent protruded through the subject microcatheter shaft.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure, the operator placed the subject microcatheter to deploy the stent.When withdrawing the subject microcatheter to deploy the stent, the operator felt friction, he tried several times to adjust by advancing the stent system and subject microcatheter but big friction was still encountered.Finally, the operator withdrew the stent and subject microcatheter out together and found part of the stent protruded through the subject microcatheter shaft.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added 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 catheter shaft was noted to be flat/crushed.The catheter shaft was noted to be stretched.The catheter shaft was noted to have hole/perforation.A functional inspection could not be performed as the stent was stuck in the subject microcatheter.Several attempts were made unsuccessfully to remove the stent, the attempts were causing further damage to the device.The microcatheter broke into 3 pieces during analysis.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 complaint was confirmed based on analysis.The device failed to meet specification 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 as per the dfu, the patients anatomy was moderately tortuous and continuous flush was maintained throughout the clinical procedure.When withdrawing the microcatheter to deploy the stent, the operator felt friction so he tried several times to adjust with advancing the stent system and microcatheter but big friction was still encountered.No anomalies were noted to the microcatheter and the stent device during the preparation step.The operator felt the stent might be overlapping causing the event.As per the microcatheter¿s dfu "never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the microcatheter or guidewire against resistance could dislodge a clot, perforate a vessel wall, or damage microcatheter and guidewire.In severe cases, tip separation of the microcatheter or guidewire may occur." the catheter shaft was found to be flattened and stretched.The concurrent stent was protruding from the microcatheter shaft.The operator tried to withdraw the stent several times which may have caused the stent to protrude through the catheter shaft.Based on the investigation results and available information, an assignable cause of procedural factors will be assigned to the reported event of ¿catheter shaft friction¿, reported and analyzed events of 'catheter shaft has hole/perforation', 'device interaction with another device' as well as the analyzed events of ¿catheter shaft flat/crushed' and 'catheter shaft stretched'.

• Brand Name: EXCELSIOR XT-27 STD PRE-SHAPED 150CM
• Common Device Name: 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: 17565301
• Report Number: 3008881809-2023-00423
• Device Sequence Number: 6665243
• Product Code: DQY
• UDI-Device Identifier: 04546540698155
• UDI-Public: 04546540698155
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2025
• Device Catalogue Number: M003XT2750910
• Device Lot Number: 24049618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEUROFORM EZ STENT (STRYKER)
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Race: Asian