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

Catalog Number	M0031681890
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner pouch of the catheter (subject device) was not sealed when the physician opened the outer packaging.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient.
Additional Manufacturer Narrative
D9 - product available to stryker - updated.D9 - returned to manufacturer on ¿ updated.H3 - device evaluated by mfg ¿ updated.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the pouch of the subject catheter was noted to be opened partially along the top (chevron) seal and the right hand side seal.The pouch appears to have been opened from the natural opening position.Although the pouch was returned open there is evidence of the pouch being sealed throughout the entire perimeter of the package.As a part of functional inspection, the seal was noted to be present.The reported event of "pouch seal (sterile barrier) is opened/unsealed" could not be replicated; however, the analysis results are consistent with the reported event.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.It was reported that when the physician opened the outer packaging of the subject microcatheter, it was found that the inner pouch was not sealed.During analysis, the pouch was noted to be opened partially along the top (chevron) seal and the right hand side seal.The pouch appears to have been opened from the natural opening position.Although the pouch was returned open there is evidence of the pouch being sealed throughout the entire perimeter of the package.Based on the review of all available information, the 'pouch seal (sterile barrier) is opened/unsealed' will be assigned a probable cause of undeterminable as while there are a number of potential causes for the reported issue, because review and analysis of available information and returned product failed to identify a definitive cause.
Event or Problem Description
It was reported that the inner pouch of the catheter (subject device) was not sealed when the physician opened the outer packaging.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient.

• Brand Name: EXCELSIOR SL-10 STRAIGHT 2 TIP 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: 23825142
• Report Number: 3008881809-2025-00720
• Device Sequence Number: 9030869
• Product Code: DQY
• UDI-Device Identifier: 04546540688217
• UDI-Public: (01)04546540688217(17)270420(10)25552183
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013789
• 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): 03/09/2026

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 Catalogue Number: M0031681890
• Device Lot Number: 25552183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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
• Patient Sex: Unknown
• Patient Race: Asian