MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF TRANSEND EX 14 FLOPPY 205CM; WIRE, GUIDE, CATHETER

Model Number	M001468070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during a liver embolization procedure the subject guidewire tip had fractured off inside the microcatheter.The subject guidewire tip remained within the microcatheter and the physician removed the microcatheter and guidewire without harm to the patient.Physician replaced the products with new devices and completed the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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.Based on the complaint information, the transcend guidewire tip broke off inside the microcatheter and remained in the microcatheter, the doctor removed the entire microcatheter and guidewire without harm to the patient.The device was not returned for analysis.As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during a liver embolization procedure the subject guidewire tip had fractured off inside the microcatheter.The subject guidewire tip remained within the microcatheter and the physician removed the microcatheter and guidewire without harm to the patient.Physician replaced the products with new devices and completed the procedure without clinical consequences to the patient.

• Brand Name: TRANSEND EX 14 FLOPPY 205CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 10311847
• Report Number: 3008853977-2020-00025
• Device Sequence Number: 14302435
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: 08714729326250
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K944677
• 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): 10/21/2020

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: 11/03/2021
• Device Model Number: M001468070
• Device Catalogue Number: M001468070
• Device Lot Number: 24711604
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 10/21/2020
• 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: PROGREAT 2 8F MICROCATHETER (UNKNOWN)