MAUDE Adverse Event Report: LAKE REGION MANUFACTURING GUIDEWIRE,0.035 AMPLATZ,5-UP; STYLET, URETERAL

Model Number 13BX

Device Problem Unraveled Material (1664)

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

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.To avoid injury to the patient, the device instructions for use document recommends ¿do not apply excessive force to advance or withdraw the guidewire.Doing so may result in complications.If resistance is encountered, determine the cause and take remedial action before continuing.¿ as a preventive measure against device damage, the instructions for use warn ¿do not reshape or alter the configuration of the guidewire.Doing so may compromise the structural integrity of the guidewire and may result in complications.¿ and ¿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.¿ prior to use, the instructions for use also state that the device should be stored in a dark, cool, dry place.

Event Description

Olympus was informed that during an unspecified urologic procedure, the clinician sensed resistance in moving the guidewire up the ureter.It was noticed that the guidewire had begun to unravel at the tip while in the patient.The guidewire was withdrawn from the patient and through the endoscope.There was no reported patient injury, and no report of any fragment missing or fallen into the patient.When the guidewire was removed from the endoscope, an approximate foot and a half length of wrapping wire unraveled from the core at the tip.

Manufacturer Narrative

This supplemental report is being submitted to provide results of dhr review.The oem could not determine the cause of the event.No sample was returned for physical analysis.The dhr was reviewed and no relevant nonconformance or anomalies were found in manufacturing, inspection or packaging at the time of product release.

• Brand Name: GUIDEWIRE,0.035 AMPLATZ,5-UP
• Type of Device: STYLET, URETERAL
• Manufacturer (Section D): LAKE REGION MANUFACTURING; 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 7963242
• MDR Text Key: 125769069
• Report Number: 2951238-2018-00612
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13BX
• Device Catalogue Number: 13BX
• Device Lot Number: 11021391
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN MODEL ENDOSCOPE