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

Model Number N/A

Device Problem Difficult to Remove (1528)

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

Event Date 11/15/2022

Event Type  malfunction  

Event Description

The user facility reported that during endoscopic retrograde cholangiopancreatography (ercp), a guidewire was inserted in an endoscopic cytology brush, then the guidewire could not be withdrawn.The guidewire and the brush were removed together from the scope and changed out.The procedure was completed with a brush and a guidewire from another manufacturer.The event occurred intra-operative.There was no patient injury/medical or surgical intervention required.The procedure was completed successfully.The final patient impact was not harmed.

Manufacturer Narrative

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, unknown.Health professional: requested, unknown.Initial reporter occupation: requested, unknown.The actual sample was stuck in the concurrently used endoscopic cytology brush (the brush) and impossible to be removed.Visual inspection found that the actual sample was protruding approximately 3075 mm from the proximal end of the brush.The brush had been buckled in the area from its proximal end to the point at 1500 mm from the distal end.The outer layer (ptfe coating) of the actual sample had peeled off in the vicinity of the proximal end of the brush.Magnifying inspection of protruding part of the actual sample found that the ptfe coating had peeled off approximately 450mm.The peeling had developed from distal to proximal and in the opposite direction and both were in straight lines.The normal part of the actual sample was dismantled so that the state of adhesion of ptfe coating could be confirmed.Magnifying inspection found no separation or gap.It was confirmed to be equivalent to a normal product.Magnifying inspection of the brush found no anomalies in appearance such as kinks or crushes in the part other than the buckled part.X-ray fluoroscopic inspection found that the distal end of the actual sample was located at approximately 2330 mm from the distal end of the brush and had been turned back proximally.Due to this, the outer surface of the actual sample and the lumen of the brush were in close contact with each other, eliminating the clearance.The buckled area of the brush that was observed was found in the same state and no clearance was observed.From this, it was considered that the sticking state was caused due to the turned-back distal end of the actual sample and the buckled part of the brush.The brush was disassembled.Visual inspection of the lumen found brown deposit in the vicinity of the turned-back distal end of the actual sample and of the buckled part of the brush.The brown deposit was subjected to component analysis by ft-ir.It was confirmed to have an ir-spectrum similar to the mixing spectrum of contrast medium and casein (protein).Ft-ir (fourier transform infrared spectroscopy) is a method of analyzing spectra obtained by irradiating an object to be measured with infrared light.From the results of the investigation, it was considered that the slid ability between the devices was compromised due to contrast medium and body fluid adhered to the surface of actual sample or the lumen of the brush, which resulted in the failure to withdraw the actual sample.The actual sample was withdrawn from the brush.Magnifying and electron microscopic inspection found scratches, roughness, and burrs on the turned-back distal end.From this, it was considered that an external load was applied to this area while it was in contact with some object.The outer diameter of the actual sample was measured and confirmed to be within the factory's control standards.Review of the manufacturing record and the shipping inspection record of the involved product code/lot number found no anomaly in them.Review of the complaint file of the involved product code/lot found no similar cases reported from other facilities.Based on the results of the investigation, as one of possibilities, it was considered that the event occurred by the following mechanism.The actual sample was inserted in the brush with its distal end having been turned-back.As a result, the clearance between the surface of the actual sample and the lumen of the brush was eliminated.In addition, contrast media and body fluid adhered to the surface of the actual sample or the inner surface of the brush for some reason, which resulted in the degraded slid ability leading to sticking state.When the actual sample in that sticking state was withdrawn, buckling occurred in the brush in the area approximately 1500 mm from the distal end to the proximal end.Due to this, the sticking state was worsened.The abrasion, roughness, and burrs in the distal end of the actual sample were considered to have occurred during insertion and removal operations.The peeling of ptfe coating of the actual sample was considered to have been caused by the application of abrasion load exceeding the limit strength of the product while some hard object (e.G., concurrently used devices) was in strong contact with the actual sample; however, the timing of the occurrence could not be clearly determined.Relevant instructions for use (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." (b)(4).

• 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: 16075559
• MDR Text Key: 308478958
• Report Number: 9681834-2022-00263
• 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
• Report Date: 12/29/2022

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-XA35455
• Device Lot Number: 25K (220511)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2022
• 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
• Treatment: BC-24Q