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

Model Number GWH3505R

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/13/2018

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 ureteroscopy procedure to crush/remove stones, the blue insulation of the guidewire broke off and fell into the patient.The patient¿s renal pelvis, ureter and bladder were thoroughly inspected but no fragment was found.It was believed that the device fragment had been flushed away.It was reported that the user felt resistance while attempting to insert the guidewire into the stent due its small diameter.The guidewire damage occurred while the user was withdrawing the stent and then observed the device fragment in the endoscopic view.The guidewire was replaced and the intended procedure was completed.There was no patient injury reported.

• Brand Name: 0.035" HYBRID WIRE, BOX OF 5
• Type of Device: 0.035" HYBRID WIRE
• Manufacturer (Section D): GYRUS ACMI, INC; ermsim schwoltbogen 24; dettingen, 72581 72581 ; GM 72581
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 7908472
• MDR Text Key: 122013559
• Report Number: 2951238-2018-00571
• Device Sequence Number: 1
• Product Code: EYA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GWH3505R
• Device Catalogue Number: GWH3505R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2018
• 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