MAUDE Adverse Event Report: EP FLEX 0.035" ANGTIP HYBRID WIRE BX/5; STYLET, URETERAL

Model Number GWH3505RA

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/15/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.Despite attempt at followup, no further information is currently available regarding the procedure, the clinical circumstances around the device breakage, or whether the procedure was completed.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 procedure, the tip of the wire broke into the patient and was retrieved.There was no reported patient injury.

Manufacturer Narrative

This supplemental report is being submitted to provide additional event information.The device has returned to olympus for evaluation, however the evaluation is still in process.The cause of the reported complaint cannot be confirmed.Additional information was received regarding the event: the tip broke off into the kidney in the middle of a flexible urs and laser procedure.The broken off tip was retrieved with a grasper.The procedure was completed using another guidewire device and the same endoscope in use when the breakage occurred.There was no reported additional bleeding, and the patient is currently doing fine.The device had been inspected prior to use with no anomalies found.The two possible endoscopes used in the procedure were either an olympus rigid cystoscope or semi rigid ureteroscope, both of which remain at the user facility site.

Manufacturer Narrative

The device was evaluated by the oem.The evaluation found thermal damage to the distal tip, potentially caused by a laser such as the reported laser device used in the procedure.As a preventive measure, the device instructions for use document contains directions for pre-procedure inspection of the device for damage.The instructions for use document also has cautions indicating that the tip must be handled carefully, such as ¿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.¿ the device history record was also reviewed and showed no related manufacturing anomalies at the time of product release.

• Brand Name: 0.035" ANGTIP HYBRID WIRE BX/5
• Type of Device: STYLET, URETERAL
• Manufacturer (Section D): EP FLEX; ermsim schwoltbogen 24; dettingen, 72581
• MDR Report Key: 7963269
• MDR Text Key: 123837239
• Report Number: 2951238-2018-00617
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2019

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: GWH3505RA
• Device Catalogue Number: GWH3505RA
• Device Lot Number: 91706342
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN MODEL OLYMPUS RIGID CYSTOSCOPE; UNKNOWN MODEL OLYMPUS SEMI RIGID URETEROSCOPE