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 07/04/2022

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.Establishment address: (b)(6).Manufacture date - unknown.Review of the manufacturing record and the shipping inspection record of the involved product code/lot number combination confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report for the involved product code/lot number combination 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 cook medical'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 cook medical 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 cook medical 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

The returned item was in a state where the actual sample was in a bag.There was nothing in the bag that was thought to be the unknown material pointed out in the complaint.Visual inspection of the actual sample taken out from the bag found no breakage or other anomalies in the appearance.Magnifying inspection of the actual sample found peeling of outer layer (ptfe coat) at multiple locations over the area approximately 150 mm - 3800 mm from the distal end.Also, the peeling had occurred almost linearly from distal to proximal or reversely.A normal part of the actual sample was disassembled.Magnifying inspection for the state of adhesion of the outer layer (ptfe coat) found no anomaly such as a gap or lifting.The outer diameter of the actual sample was measured and confirmed to meet the factory's specifications.No anomaly was observed.Outer diameter of the urethane coated area: 0.59 mm.Outer diameter of the distal part of ptfe coated area: 0.59 mm.Outer diameter of the proximal part of ptfe coated area: 0.57 mm.From the investigation results, as one of the possibilities in this case, it was inferred that the actual sample was exposed to abrading force exceeding the limit strength of the product while being in strong contact with some kind of hard object (such as the device used in combination), which resulted in the peeling of outer layer.However, since the details of the occurrence situation were unknown, it was not possible to clarify the timing of occurrence.Relevant instructions for use (ifu) reference: "use this instrument only in combination with products recommended by olympus.If combined with products not recommended by olympus, patient or operator injury, malfunction or equipment damage may result." "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: 15182626
• MDR Text Key: 305087409
• Report Number: 9681834-2022-00161
• 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: 08/08/2022

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-XA25455
• Device Lot Number: 1YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 10/06/2022
• Supplement Dates FDA Received: 10/31/2022
• 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: COOK MEDICAL'S KNIFE (TYPE: UNKNOWN).