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

Catalog Number M0031681900

Device Problem Break (1069)

Patient Problems Death (1802); Device Embedded In Tissue or Plaque (3165)

Event Date 05/12/2017

Event Type  Death  

Manufacturer Narrative

The subject device is not available.

Event Description

The broken device was unable to be retrieved and remained inside the patient.No further information is available.

Manufacturer Narrative

Outcomes attributed to ae: updated.Based on the additional information received from the facility executive summary is updated for patient death.Type of reportable event: updated.Patient code grid : added code for death.A review of the device history record could not be performed because the lot number was not reported.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.There are many potential root causes for the as reported event, however a review and analysis of all available information cannot determined the exact cause for the reported catheter break and device fragments in the patient.However, death is a known risk associated with endovascular procedure and/or patient condition and is noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to patient death.

Event Description

It was reported that during the procedure, the broken device was unable to be retrieved and remained inside the patient.User facility informed that the patient passed away.No further information is available.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 45 150CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6632622
• MDR Text Key: 77272275
• Report Number: 3008881809-2017-00182
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0031681900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other