MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA SINGLE USE GUIDWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number OL-XS25455

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2021

Event Type  Injury  

Manufacturer Narrative

Expiration date - unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacturer date - unknown due to unknown lot number.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.Review of the manufacturing record and the product release decision control sheet of the involved product code/lot# combination over the past three years (december 2018 to november 2021) confirmed that there were not any indications of anomaly in them.(b)(4).

Event Description

The user facility reported that the single use guidewire was used during the procedure.During the ercp case, the distal end of guidewire fractured and dislodged in the patient's body despite normal use.The dislodged piece was retrieved, and the device was replaced with similar one to complete the procedure.There was no harm to the patient other than the device being dislodged.The procedure was completed successfully.The patient was harmed; it was not serious injury.

Event Description

Additional information was received on 22nov2021: in order to remove bile duct stones, the product was used in combination with tjf-q290v (olympus) and a lithotripter (manufacturer unknown), and crushed bile duct stones 4 or 5 times.At that time, the distal end of involved product was damaged.The guidewire was used in a considerably bent state when crushed bile duct stones.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information in section b5 and d10, to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.The returned sample was a combination of disposable guidewire g (actual sample) and a cholangiography catheter.Visual inspection of the actual sample found that it had been fractured at approximately 75mm from the distal end.Magnifying and electron microscopic inspections of the actual sample revealed that the vicinity of fractured section had been curved.The shape of the side surface of fractured section was inclined, and a radial pattern was found on the top surface of fractured section.X-ray fluoroscopic inspection of the lumen of cholangiography catheter revealed that the fractured section of actual sample was detected at 1060mm from the distal end of cholangiography catheter.The vicinity of fractured section had been curved.The shape of the side surface of fractured section was inclined.No anomaly such as a crush was found in the vicinity of fractured section of the lumen of cholangiography catheter.The outer diameter of actual sample (normal section) was measured and confirmed to meet the specifications.Outer diameter of urethane outer layer: 0.593mm.Outer diameter on the rear end of ptfe coat: 0.569mm.Simulation test: the following force was applied using a factory-retained normal disposable guidewire g.As a result, the fracture was observed.Then, electron microscopic inspection was performed for the fractured section of simulated wire.Following results were obtained: when repeated bending force (90 ° folded bending force) is applied: the shape of side surface of the fractured section of wire was inclined, and a radial pattern was found on the top surface of fractured section.Since the fractured condition of simulated product and the fractured condition of actual sample were similar, it was presumed that the same force as the above simulation test was applied to the actual sample.Ifu states: if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the guide wire and/or endotherapy accessory and determine the cause by fluoroscopy or endoscope.Continuing to manipulate the guidewire could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It may also damage the endoscope, instrument and/or endotherapy accessory.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It was likely that the following mechanism was inferred.From the reported issue that "the guidewire was used in a considerably bent state when crushed bile duct stones", it was inferred that bending force was applied to the actual sample.In that state, some force (e.G.Bending force in the opposite direction, contact with lithotripter) was applied, resulting in fracture.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: SINGLE USE GUIDWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: mary o'neill ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12982673
• MDR Text Key: 282280444
• Report Number: 9681834-2021-00232
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OL-XS25455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 12/22/2021
• 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
• Treatment: LITHOTRIPTER MANUFACTURER UNKNOWN; OLYMPUS TJF-Q290V
• Patient Outcome(s): Required Intervention