MAUDE Adverse Event Report: EP FLEX 0.038" HYBRID WIRE, BOX OF 5

Model Number GWH3805R

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the event cannot be determined at this time.However, this type of guidewire damage is most likely related to the operator's technique.The instruction manual contains several warning and caution statements in an effort to prevent damage to the guidewire." inspect the device for any visible damage such as kinks, unwound coil, abrasion at the tip etc.Carefully and slowly withdraw the guidewire from the patient to avoid any damage.The tips of some metal instruments may cause the coating material on the guidewire to be scraped off under conditions of sharp bending or kinking.If this occurs, it is recommended that any fragments of the outer coating material be removed.While advancing or withdrawing any coated guidewire, avoid sharply bending or kinking the portion of the guidewire that extends beyond the instrument.¿.

Event Description

Olympus was informed that during an unspecified procedure, as the surgeon began to withdraw the guidewire the distal end began to unravel in the patient.The user facility reported no device fragment from the guidewire or the guidewire's insulation fell inside the patient.The surgeon was able to retrieve the guidewire without intervention.The intended procedure was completed with the same guidewire.The procedure was delayed 5 minutes.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the original equipment manufacturer (oem) device investigation results.The device was returned to the oem for investigation.The investigation confirmed the reported device issue.The distal tip of the device was found separated, yet remained tethered to the remainder of the guidewire by the unraveled coil wire.The distal tip section was advanced through the stent with the unraveled coil wire remaining within the stent over its full length.The coil and pebax distal tip showed no signs of compressive force which would likely cause the reported device issue.The oem performed a device history review and found no deviations or irregularities in the production of the reported device.All process steps and all inspections were completed according to standard specifications.

• Brand Name: 0.038" HYBRID WIRE, BOX OF 5
• Type of Device: 0.038" HYBRID WIRE
• Manufacturer (Section D): EP FLEX; ermsim schwoltbogen 24; dettingen, 72581
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 7075400
• MDR Text Key: 94897488
• Report Number: 2951238-2017-00752
• Device Sequence Number: 1
• Product Code: EYA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GWH3805R
• Device Catalogue Number: GWH3805R
• Device Lot Number: 91604399
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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