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

Model Number GWH3805R

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

The referenced device was not returned for evaluation.The cause of the reported event cannot be determined at this time.However, 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

The manufacturer was informed that near the end of a therapeutic cystoscopy/ureteroscopy with stent placement procedure, the doctor was placing a stent when the blue outer coating of the device flaked off inside the patient.The device fragments were flushed/suctioned out of the patient.The procedure was completed using the same device.Additionally, there was no bleeding to the patient and the patient did not require a longer stay or additional procedures.The procedure was not prolonged.There was no patient injury or harm reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the device evaluation and the oem's investigation.The device was returned for the reported blue coating flaking off.The device arrived inside its tyvek pouch, inside a plastic bag.Upon inspection, the guide wire was missing part of the outer blue coating in the middle of the guide wire; roughly 28" from the distal end of the wire.In the same spot, there was also part of the blue coating that was loose, sliding back and forth on the wire in the space where coating was missing.There was no deviation or irregularities found upon reviewing the dhr.The oem reported that the failure mode likely occurred during the procedure due to the stress and signs observed on the device as it was subjected to forces that greatly exceeded design expectations resulting in product failure.

• Brand Name: 0.038" HYBRID WIRE, BOX OF 5
• Type of Device: HYBRID WIRE
• Manufacturer (Section D): EP FLEX; ermsim schwoltbogen 24; dettingen, 72581 72581 ; GM 72581
• MDR Report Key: 8862229
• MDR Text Key: 163560456
• Report Number: 2951238-2019-01040
• Device Sequence Number: 1
• Product Code: EYA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT-EYA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

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
• Device Operator: Health Professional
• Device Model Number: GWH3805R
• Device Lot Number: 91807218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 08/08/2019
• Supplement Dates FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1