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

Catalog Number OL-XA25453

Device Problem Material Separation (1562)

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

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Udi not required for product code.Implanted date: device was not implanted.: explanted date: device was not explanted.This report has been deemed reportable based upon visual inspection of the actual sample upon receipt.The actual sample was received for evaluation.The actual guidewire g sample was received in the state of having been combined with the papillotomy knife.The guidewire was referred to as sample 1 and the papillotomy knife as sample 2 in this report.Visual inspection of sample 1 and 2 revealed that sample 1: the urethane coat had been broken and separated from the core wire on approximately 65 - 75 mm from the distal end and buckled on approximately 50 - 65 mm from the distal end.The core wire was exposed.Sample 2: the tube had been ripped on 0 mm - 100 mm from the distal end.Sample 1 was protruding through the rip.Magnifying inspection of sample 2 found that the rip had extended from the distal to proximal direction.An attempt was made to separate sample 1 from sample 2, however, failed.Sample 1 was pushed forward, and then separated from sample 2 successfully.Magnifying inspection of the buckled section revealed that the buckling had developed in the proximal direction.Some tears were observed on in the buckled section.The tears in sample 1 were inspected under electron microscope.No abrasions were found on the surface around the tears.Torn surface was found relatively smooth and stretched urethane connecting the torn ends was observed.From this, it is likely that, when the buckling occurred, a compressing load was generated and exerted on the area distal to the buckling area, which resulted in the tears.Magnifying inspection of the broken point of the urethane coat revealed that the urethane had been stretched and torn.No other anomaly was observed in sample 1 other than the above-mentioned damage.The outer diameter of sample 1 was measured and confirmed to meet the factory's control criteria.An attempt was made to combine a factory-retained guidewire g with sample2.As a result, no projection of the guidewire from sample 2 was confirmed.From this, it was likely that the protrusion of sample 1 developed as the rip in sample 2 developed.Another attempt was made to protrude the guidewire g sample from the rip of sample 2 intentionally, and then, to remove the guidewire.As a result, the guidewire was caught in the rip of sample 2.Subsequently, when the guidewire was pulled further, buckling of urethane coat occurred in the guidewire.Since the degree of buckling was mild compared to the state of the sample 1, it was presumed that sample 1 was subjected to a stronger removal load.A review of the device history record and the shipping inspection record of the involved product code/lot# combination was conducted with no findings.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 is likely that sample 1 was trapped in a hard object including a lesion, and at the same time, the distal end of sample 2 was exposed to a hard object including a lesion with resultant rip.When the slider of sample 2 was pulled to tense the knife wire, the tensile load was exerted on sample 1 causing it to protrude from the rip on sample 2 and to be caught in it.When sample 1 in that state was pulled, the urethane coat was broken and buckled, and a compressing load generated by the buckling caused the tears on the urethane coat.At that time, the pulling load to sample 1 made the rip in sample 2 spread.When further pulling load was applied to sample 1, the rip in sample 2 became larger.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the involved single use guidewire was used during the procedure.Projection of guidewire occurred at approximately 10 cm from the distal end of an olympus-made papillotomy knife ((b)(4)).They discontinued using it and completed the procedure with (b)(4).There was no impact on patient health.The procedure was completed successfully.The patient was not harmed.

• 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: theresa mussaw ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 11026666
• MDR Text Key: 222763908
• Report Number: 9681834-2020-00244
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2020

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 Expiration Date: 03/31/2023
• Device Catalogue Number: OL-XA25453
• Device Lot Number: 200415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2020
• 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