MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 90 150CM; CATHETER, PERCUTANEOUS

Model Number	M0031681910
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During the procedure the radiography was not successful, so the physician checked carefully and found that the distal section of the microcatheter (subject device) was broken.The physician then withdrew the microcatheter and the guidewire together, and the guidewire was also found to be broken.The broken part of the guidewire and microcatheter were snared from the vessel.The procedure was completed successfully after changing the devices.No clinical consequences reported to the patient.
Additional Manufacturer Narrative
Product available to stryker: updated.Lot #: updated based on additional information received.Unique identifier (udi) #: updated based on additional information received.Expiration date: added.Returned to manufacturer on: updated.Device evaluated by mfg: updated summary attached: updated.Manufacturing date: added.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the catheter shaft was broken.A patency test could not be performed as the catheter shaft was broken.Additional information reported that the microcatheter was confirmed to be in good condition after unpacking and during preparation and appears to have been used as per the dfu.The damage noted to the microcatheter is indicative of excessive force though this cannot be conclusively determined.An assignable cause of procedural factors will be assigned to the reported 'catheter shaft broken/fractured', 'catheter kinked/bent' and the analysed 'catheter shaft broken/fractured' as the issue is associated with a product that meets stryker design and manufacture specifications and was used according to the dfu but due to procedural and/or anatomical factors during use, the device performance was limited.
Event or Problem Description
During the procedure the radiography was not successful, so the physician checked carefully and found that the distal section of the microcatheter (subject device) was broken.The physician then withdrew the microcatheter and the guidewire together, and the guidewire was also found to be broken.The broken part of the guidewire and microcatheter were snared from the vessel.The procedure was completed successfully after changing the devices.No clinical consequences reported to the patient.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 90 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6711505
• Report Number: 3008881809-2017-00208
• Device Sequence Number: 13887210
• Product Code: DQY
• UDI-Device Identifier: 04546540688231
• UDI-Public: (01)04546540688231(17)180331(10)19005925
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: M0031681910
• Device Catalogue Number: M0031681910
• Device Lot Number: 19161728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Initial Date Received by Manufacturer: 06/16/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNCHRO GUIDEWIRE (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 60