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

Catalog Number	M0031681910
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Upon removal of the subject device from the patient¿s body, the physician observed saline leaking near the strain relief of the microcatheter.There were no clinical consequences reported due to this event.
Additional Manufacturer Narrative
Upon removal of the subject device from the patient¿s body, the physician observed saline leaking near the strain relief of the microcatheter.There were no clinical consequences reported due to this event.
Event or Problem Description
Upon removal of the subject device from the patient¿s body, the physician observed saline leaking near the strain relief of the microcatheter.There were no clinical consequences reported due to this event.

• 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: 6149034
• Report Number: 3008881809-2016-00292
• Device Sequence Number: 53103
• Product Code: DQY
• UDI-Device Identifier: 04546540688231
• UDI-Public: (01)04546540688231(17)180430(10)19087270
• Combination Product (Y/N): N
• 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): 04/26/2017

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: 04/30/2018
• Device Catalogue Number: M0031681910
• Device Lot Number: 19087270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 04/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1