MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SILVERSPEED; WIRE, GUIDE, CATHETER

Model Number	103-0602-200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The silverspeed-14 guidewire (model: 103-0602-200 lot: 201704069e) was returned for analysis within a shipping box; within a plastic pouch; within an opened silverspeed-14 inner pouch and within a dispenser coil.The echelon-14 micro catheter (pli-20) was not returned.The reason for the echelon-14 micro catheter not returning was not provided.The echelon-14 micro catheter has a labeled id (inner diameter) of 0.017" and the silverspeed-14 guidewire has a labeled od (outer diameter) of 0.014¿.As per the product labeling, the echelon-14 micro catheter is compatible for use with guidewires with a maximum od of 0.014¿.Therefore, the silverspeed-14 guidewire was found to be compatible for use with the echelon-14 micro catheter.No damages and irregularities were found with the guidewire proximal solder region.The guidewire outer coils were found to be stretched at ~11.3cm from proximal solder region.The guidewire inner core wire was found to be broken at ~16.2cm from the proximal solder region.When compared to product drawing ~3.8cm of the inner core wire was found to be missing.In addition, the guidewire distal tip was found to be missing.The od (outer diameter) of the guidewire proximal solder region was measured to be 0.0133¿ which is within specification (specification 0.0140¿ max).Due to its damaged condition, the silverspeed-14 guidewire could not be used for testing with an in-house micro catheter.The broken core wire will be sent out for sem (scanning electron microscopy) analysis.No other anomalies were observed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report of silverspeed guidewire resistance in an echelon catheter prior to a procedure.After becoming stuck, the silverspeed was withdrawn from the echelon.It was noted that the silverspeed tip was bent and "completely damaged." the silverspeed was replaced with an xpedion 14 to continue the procedure.The echelon catheter had been flushed and the guidewire had been hydrated as indicated in the ifu.There were no reports of patient injury in association with this event.

• Brand Name: SILVERSPEED
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 8009591
• Report Number: 8020889-2018-00097
• Device Sequence Number: 1683756
• Product Code: DQX
• UDI-Device Identifier: 00847536004566
• UDI-Public: 00847536004566
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2018

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: 10/31/2019
• Device Model Number: 103-0602-200
• Device Catalogue Number: 103-0602-200
• Device Lot Number: 201704069E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR