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

Catalog Number OL-XA25455

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

Expiration date - unknown due to unknown lot number.Udi - not required for product code.Initial reporter name: unknown.Health professional : unknown.Occupation: unknown.Device manufacture date - unknown due to unknown lot number.Two devices were received for evaluation; hereinafter, they are referred as sample 1 and sample 2.Visual inspection revealed that sample 1; the outer layer (ptfe coat) had been sheared off the wire at approx.80, 85 and 220mm from the distal end of the device, and sample 2; the outer layer (ptfe coat) had been sheared off the wire at approximately 205mm from the distal end of the device.The outer layer (ptfe coat)-sheared section was inspected under magnification.Sample 1: at 80mm the outer layer (ptfe coat) had been completely sheared off the wire; at 85mm the shearing of the outer layer had occurred in the proximal direction; at 220mm the shearing of the outer layer had occurred in the distal direction, sample 2: at 205mm the shearing of the outer layer had occurred in the proximal direction.These states indicate that the actual device has been abraded with a sharp-edged object.There was no other anomaly on the remainders of the device.The outside diameter of the ptfe coated segment was measured on the undamaged section and confirmed to meet the specifications.The undamaged outer layer (ptfe coat) was removed from the core wire to evaluate the state of the adhesion of the outer layer (ptfe coat) to the core wire.Magnifying inspection confirmed it was equivalent to that of the current product sample with no lifted or gapped section on the coat.Reproductive testing was performed on a current product sample of the visiglide guide wire.The test sample was let to have contact with a sharp tool (in this test, a metal plate approximately 1mm in thickness was utilized) on the ptfe coated segment by pushing the ptfe coated segment against the sharp tool.In this state the test sample was pulled in the proximal direction.The coating was sheared off the shaft and some sheared portions came off the shaft.From this result, it is likely that the damage was generated on the actual device when the actual device was pulled in the proximal direction.The test sample was let to have contact with an inserter on the outer layer (ptfe coat) by pushing the outer layer (ptfe coat) segment against the inserter.In this state the test sample was pulled in the proximal direction.No damage was generated on the shaft.The test sample was fixed to a plastic torque device gently on the outer layer (ptfe coat).In this state the test sample was pulled in the proximal direction.Some scratches were generated in the distal direction on the outer layer (ptfe coat).No peeling of the outer layer (ptfe coat) occurred.The forceps elevator on the endoscope was raised while a guide wire is inserted in it.The guide wire came into close contact with the forceps elevator.Subsequently when the guide wire was subjected to further pushing and pulling forces in this state, it was exposed to a frictional force exceeding the product's strength limit, resulting in shearing of the outer layer (ptfe coat) off the shaft.A review of the device history record of the 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.Continuing to manipulate the guide wire could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It may also damage the endoscope, instrument and /or endo therapy 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 the samples were exposed to abrading force which exceeded the strength limit of this product by coming very close contact with a hard object, resulting in the shearing of the outer layer (ptfe coat).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 actual single use guidewire was unpacked and inserted into an angiographic tube, when the customer perceived some frictional resistance which was stronger than usual.The customer stopped using it.The event occurred pre-treatment.

• 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: 8807001
• MDR Text Key: 159193625
• Report Number: 9681834-2019-00129
• 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: 07/19/2019

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: 02/28/2022
• Device Catalogue Number: OL-XA25455
• Device Lot Number: 190319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2019
• 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