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

Model Number N/A

Device Problem Particulates (1451)

Patient Problem Insufficient Information (4580)

Event Date 06/28/2022

Event Type  malfunction  

Manufacturer Narrative

Expiration date: unknown.Udi: n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter name - requested, not provided.Establishment address: korea.Health professional- requested, not provided.Occupation- requested, not provided.Manufacture date - unknown.Review of the manufacturing record and the shipping inspection record of the (b)(6) 2021 lot (1zk) confirmed there was no indication of anomaly in them.A search of the complaint file found no other similar report with the (b)(6) 2021 lot (1zk) from other facilities.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 user facility reported that the olympus guide wire involved was used with a micro-tech's knife.It was confirmed that an unknown material (bodily secretion, guidewire debris, knife debris or another residue substance etc.But could not be specified) was generated during the procedure.The micro-tech knife was inspected by port flushing before use.The guidewire was also visually inspected before use, then inserted into the endoscope to perform a bile duct cannulation.During the use of the guidewire, while maintaining the cannulation, only the micro-tech knife was pulled out and flushed.An unknown material (bodily secretions, guidewire debris, knife debris or another residue substance etc.But could not be specified) was discharged.The event occurred intra-operative.There was no patient injury.No medical or surgical intervention was required.The final patient impact was not harmed.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The actual product and sample product were returned.Each product contained a guidewire and a foreign substance.Magnifying inspection of the actual guidewire found many scratches in various places in the range from approximately 1000mm from the distal end to the rear end.Magnifying inspection of the sample guidewire found many scratches in various places in the range from approximately 2000mm from the distal end to the rear end.Qualitative analysis of foreign substance in the actual product and sample product were performed by ft-ir.Each foreign substance was likely to be polytetrafluoroethylene (ptfe).The outer diameters of the actual product and the sample product were measured and confirmed to meet the specifications.The actual sample: the outer diameter of the urethane outer layer was 0.59mm.The outer diameter of the ptfe outer layer (distal side) was 0.60mm.The outer diameter of the ptfe outer layer (rear end side) was 0.58mm.The sample product: the outer diameter of the urethane outer layer was 0.59mm.The outer diameter of the ptfe outer layer (distal side) was 0.60mm.The outer diameter of the ptfe outer layer (rear end side) was 0.58mm.Review of the manufacturing record and the shipping inspection record of the involved product code/lot number combination confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination from other facilities.Based on the investigation result, it was likely that when the actual product was in strong contact with a hard object (e.G.The device used in combination), abrasion force exceeding the limit strength of the product was applied, resulting in foreign substance.However, since the details of the circumstances of the occurrence were unknown, it was not possible to clarify when the event occurred.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.".

• 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 15129779
• MDR Text Key: 304532082
• Report Number: 9681834-2022-00141
• Device Sequence Number: 1
• Product Code: OCY
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

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-XS25455
• Device Lot Number: 1ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/04/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 08/06/2022
• Supplement Dates FDA Received: 09/06/2022
• 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: MICRO-TECH KNIFE.