MAUDE Adverse Event Report: GYRUS ACMI, INC 0.035" HYBRID WIRE, BOX OF 5

Model Number GWH3505R

Device Problem Unraveled Material (1664)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

The customer's complaint of the guidewire unraveling could not be confirmed since the device was discarded at the user facility and was not returned to olympus for evaluation.Therefore, due to the lack of information, the root cause cannot be determined.If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.Device was discarded.

Event Description

The customer had two ultratrack wires unravel during one case.Once inside the patient and the other putting it inside the patient.The customer discarded the wires so we do not have any product information see complaint# (b)(4) for the first device used in the same procedure.

• Brand Name: 0.035" HYBRID WIRE, BOX OF 5
• Type of Device: WIRE
• Manufacturer (Section D): GYRUS ACMI, INC; ermsim schwoltbogen 24; dettingen, 72581 72581 ; GM 72581
• Manufacturer Contact: terrence sullivan ; 136 turnpike road; southborough, MA 01772 ; 5088042739
• MDR Report Key: 7556875
• MDR Text Key: 109771314
• Report Number: 3005975494-2018-00008
• Device Sequence Number: 1
• Product Code: EYA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT-EYA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GWH3505R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2018
• 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