MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED J 150CM; CATHETER, PERCUTANEOUS

Model Number	M0031681920
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject microcatheter was inspected and confirmed to be in good condition during/after unpacking as described in device directions for use (dfu).After the subject microcatheter was placed in the patient, advance along vessel could not be followed on the angiography device.The physician thinks microcatheter has no marker.Therefore, the subject microcatheter was removed.The procedure was completed with a different device.The patient was stable after the procedure.No other information was provided.
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 inspection of the device revealed that the distal marker band and catheter tip had detached, and the catheter shaft was seen to be flat/crushed at approximately 6cm from the distal tip.The proximal marker band was seen to be present.The functional evaluation was not required as the ro marker had detached.The reported event was confirmed 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.Additional information received from the customer indicated that no anomalies were noted to the device or packaging before use, continuous flush was setup and maintained throughout the procedure and the device was prepared as per the dfu.After the sl-10 microcatheter was placed in the patient, advance along vessel could not be followed on the angiography device.The damage noted to the device would be indicative of the as reported event.It was seen that the microcatheter distal marker and catheter tip outer layer were detached.The as reported 'ro marker missing' was not confirmed as it was seen during analysis that the catheter distal marker band and the catheter tip outer layer had detached.The as reported 'ro marker missing' will be assigned not confirmed.However, the distal marker band and catheter tip had detached, and the catheter shaft was seen to be flat/crushed at approximately 6cm from the distal tip.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.Based on this investigation, the as reported ¿device difficulty engaging target vessel¿ as well as the as analysed ¿catheter tip broken/fractured during use', 'ro marker(s) detached/separated/not visible under fluoroscopy' and ¿ catheter shaft flat/crushed' will be assigned procedural factors as these defects appear to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.
Event or Problem Description
It was reported that the subject microcatheter was inspected and confirmed to be in good condition during/after unpacking as described in device directions for use (dfu).After the subject microcatheter was placed in the patient, advance along vessel could not be followed on the angiography device.The physician thinks microcatheter has no marker.Therefore, the subject microcatheter was removed.The procedure was completed with a different device.The patient was stable after the procedure.No other information was provided.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED J 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: 12668796
• Report Number: 3008881809-2021-00442
• Device Sequence Number: 4212396
• Product Code: DQY
• UDI-Device Identifier: 04546540688248
• UDI-Public: 04546540688248
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K042568
• 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): 01/06/2022

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: 01/07/2023
• Device Model Number: M0031681920
• Device Catalogue Number: M0031681920
• Device Lot Number: 22670592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 12/25/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2021
• 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
• Patient Sex: Unknown