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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2022

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter health professional: requested, unknown.Initial reporter occupation: other.The actual device was not available; therefore, the actual device will not be returned for evaluation.The manufacturing record and the shipping inspection record of the product of the involved product code/lot number was performed and no anomaly was found.The past complaint file of the involved product code/lot number, no other similar report of the product with the involved product code/lot number from other facilities was found.Through the past simulation test, we have experienced that the guidewire was cut when the following each force was applied.In addition, we have been aware that there was regularity in the shape of the cut section of wire depending on the mechanism leading to cutting.When pulling force was applied, the side of fractured section of the wire was tapered, and a dimple pattern (a hole-shaped pattern) was found on the fracture surface.When torque force was applied alternately to the left and right, the side of fractured section of the wire was flat, and a spiral pattern was found on the fracture surface.When 90° repeated bending force was applied, the side of fractured section of the wire was tilt, and a radial pattern was found on the fracture surface.Based on the investigation result, as a possible cause of this case, it was inferred that the actual product was caught in the forceps base of the endoscope used in combination, and some excessive force (e.G., pulling force, torque force or bending force) was applied to the involved section, leading to the cutting.However, since the actual sample was not returned, the cause of occurrence could not be clarified.Instructions for use (ifu): "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." terumo medical products (tmp) (importer) registration no: (b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no: (b)(4).

Event Description

The sales representative reported an out of box failure for the g-260-2527 a viziglide wire involved.During the procedure the g-260-2527 a snagged the elevator of the t jf-q 190v and the wire snapped.The procedure was able to be completed using a second g-260-2527 a wire.This was an out of box failure.Additional information was received on 11 jan 2023: the procedure performed was an endoscopic retrograde cholangiopancreatography (ercp).The event occurred intra-operative.The procedure was completed with a second device.The patient was in stable condition.The procedure was successful.There was no blood loss.The device broke outside the body.The user of the device was able to pull the device back thru the scope when it looked damaged at approximately 6-7cm from the distal tip.

Manufacturer Narrative

This report is being submitted as follow-up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted, however, a photograph was provided and analyzed.1.The manufacturing record and the shipping inspection record of the product of the involved product code/lot number · no anomaly was found.2.The past complaint file of the involved product code/lot number · no other similar report of the product with the involved product code/lot number from other facilities was found.3.Confirmation of the provided photo · the provided photo was confirmed.It was found that the distal end of actual sample was cut off and the ptfe coating was peeled off.4.Through the past simulation test, we have experienced that the guidewire was cut when the following each force a) - c) was applied.In addition, we have been aware that there was regularity in the shape of the cut section of wire depending on the mechanism leading to cutting.A) when pulling force was applied - the side of fractured section of the wire was tapered, and a dimple pattern (a hole-shaped pattern) was found on the fracture surface.B) when torque force was applied alternately to the left and right - the side of fractured section of the wire was flat, and a spiral pattern was found on the fracture surface.C) when 90° repeated bending force was applied - the side of fractured section of the wire was tilt, and a radial pattern was found on the fracture surface.Based on the investigation result, as a possible cause of this case, the following mechanism was inferred.However, since the actual sample was not returned, the cause of occurrence could not be clarified.It was inferred that the actual product was caught in the forceps base of the endoscope used in combination, and some excessive force (e.G.Pulling force, torque force or bending force) was applied to the involved section, leading to the cutting.As a possible cause of the peeling of ptfe coating, it was inferred that abrasion force was applied to the involved section.Relevant ifu reference: "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." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: SINGLE USE GUIDWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16169849
• MDR Text Key: 307473933
• Report Number: 9681834-2022-00278
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 54953170358208
• UDI-Public: 54953170358208
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2023

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: N/A
• Device Catalogue Number: OL-XA25275M
• Device Lot Number: 25K (220512)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/14/2023
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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