MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 45 150CM; CATHETER, PERCUTANEOUS

Model Number	M0031681900
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the returned device was found to be broken/fractured.Only one part of the catheter was returned.The reported event could not be confirmed as the analysis was very limited due to condition of the returned device.The reported defect was not confirmed based on analysis of the device.The subject catheter did not meet specifications when received for complaint investigation.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 provided by the customer indicated that continuous flush was maintained throughout the procedure.The subject catheter shaft was found to be fractured and was only partially returned.The as reported catheter, difficulty advancing coil was not confirmed during analysis as the analysis was very limited due to condition of the returned device.The device was returned, and a review of analysis and all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of not confirmed will be assigned to the as reported.The as analyzed catheter shaft broken/fractured during use will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
Event or Problem Description
The subject device was returned for analysis and the device investigation revealed that subject catheter shaft was broken/fractured during use.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the returned device was found to be broken/fractured.Only one part of the catheter was returned.The reported event could not be confirmed as the analysis was very limited due to condition of the returned device.The reported defect was not confirmed based on analysis of the device.The subject catheter did not meet specifications when received for complaint investigation.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 provided by the customer indicated that continuous flush was maintained throughout the procedure.The subject catheter shaft was found to be fractured and was only partially returned.The as reported catheter, difficulty advancing coil was not confirmed during analysis as the analysis was very limited due to condition of the returned device.The device was returned, and a review of analysis and all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of not confirmed will be assigned to the as reported.The as analyzed catheter shaft broken/fractured during use will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
Event or Problem Description
The subject device was returned for analysis and the device investigation revealed that subject catheter shaft was broken/fractured during use.No clinical consequences were reported to the patient due to this event.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 45 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: 13481911
• Report Number: 3008881809-2022-00054
• Device Sequence Number: 20136223
• Product Code: DQY
• UDI-Device Identifier: 04546540688224
• UDI-Public: 04546540688224
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 02/08/2022

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: 10/13/2022
• Device Model Number: M0031681900
• Device Catalogue Number: M0031681900
• Device Lot Number: 22518511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2020
• 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: TARGET COIL (STRYKER)
• Patient Age: 57 YR
• Patient Sex: Female