MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT 27 MC FLEX PRESHAPED 150; CATHETER, PERCUTANEOUS

Catalog Number	M003XT2750920
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that the subject microcatheter was navigated successfully to the left pca.When the physician started to advance a stent in the microcatheter, resistance was encountered and the physician noted that the microcatheter was broken.The microcatheter and stent where removed out of the patient through the guide catheter.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
Expiration date: updated, product available to stryker: updated, reporting contact: corrected, device evaluated by mfg: updated, manufacturing date: updated.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The microcatheter was returned with a stent system.Visual inspection revealed that the catheter was broken/fractured at two locations.Blood was noted within the rhv and the microcatheter hub.During functional evaluation, the stent as well as a 0.020¿ patency mandrel was advanced through the microcatheter and resistance was experienced at the break/ fracture location.The 0.020¿ patency mandrel was advanced through the distal section resistance was experienced and the mandrel was unable to be advanced, therefore the microcatheter was cut and solidified was blood blocking the microcatheter shaft.The microcatheter was flushed and blood exited the distal end of the microcatheter.Information available confirmed the device to be in good condition prior to use.Based on the device analysis and information currently available it is likely that procedural factors contributed to the reported and observed anomalies limiting the performance of the device during the clinical procedure.Therefore, an assignable cause of operational context has been assigned to this investigation.
Event or Problem Description
It was reported that the subject microcatheter was navigated successfully to the left pca.When the physician started to advance a stent in the microcatheter, resistance was encountered and the physician noted that the microcatheter was broken.The microcatheter and stent where removed out of the patient through the guide catheter.There were no reported clinical consequences to the patient.

• Brand Name: EXCELSIOR XT 27 MC FLEX PRESHAPED 150
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6487817
• Report Number: 3008881809-2017-00108
• Device Sequence Number: 11084866
• Product Code: DQY
• UDI-Device Identifier: 04546540698162
• UDI-Public: (01)04546540698162(17)190630(10)19147684
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K113778
• 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): 07/17/2017

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: 06/30/2019
• Device Catalogue Number: M003XT2750920
• Device Lot Number: 19147684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 07/17/2017
• 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: ENVOY MPC GUIDE CATHETER (DEPUY SYNTHES); NEUROFORM EZ STENT (STRYKER)