MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-17 FLEX STRAIGHT 150CM; CATHETER, PERCUTANEOUS

Model Number	M003C1715ST0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Prior procedure, the patient presented with subarachnoid hemorrhage (sah) and acoma aneurysm.The guidewire was used to deliver the echelon-10 microcatheter to the aneurysm and then filled with coils.When delivering the stent into the subject microcatheter, the resistance was encountered and the catheter shaft (subject device) near the hub was fractured when delivered with force.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
Prior procedure, the patient presented with subarachnoid hemorrhage (sah) and acoma aneurysm.The guidewire was used to deliver the echelon-10 microcatheter to the aneurysm and then filled with coils.When delivering the stent into the subject microcatheter, the resistance was encountered and the catheter shaft (subject device) near the hub was fractured when delivered with force.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and microscopic examination of the returned subject catheter hub was seen to be separated from the catheter shaft and the shaft was stretched.Additionally, the catheter shaft was seen to be kinked/bend approx.41cm, 44cm, 97cm,100cm and 141cm from the proximal end.Functional testing could not be performed due to the condition of the device.However, 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 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 there was no damage noted to the packaging prior to opening the packaging.Also additional information provided by the customer indicated that the device was in good condition prior to use.The excelsior xt-17 catheter would not have left the manufacturing process in the returned condition due to the controls in place in the manufacturing process.The catheter hub was detached and the shaft was found to be stretched.The catheter shaft was found to be kinked.The catheter hub may have become detached due to force applied during the procedure trying to deliver the xt17 catheter.The as reported as well as the as analysed will be assigned 'procedural factors' as 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/or anatomical factors during use, the product performance was limited.

• Brand Name: EXCELSIOR XT-17 FLEX STRAIGHT 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: 15772740
• Report Number: 3008881809-2022-00563
• Device Sequence Number: 19598692
• Product Code: DQY
• UDI-Device Identifier: 07613252714903
• UDI-Public: 07613252714903
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142565
• 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): 12/14/2022

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: 01/03/2023
• Device Model Number: M003C1715ST0
• Device Catalogue Number: M003C1715ST0
• Device Lot Number: 22661097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2021
• 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: ECHELON-10 MICROCATHETER; STENT (UNKNOWN MANUFACTURER); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Race: Asian