MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RUNTHROUGH NS; WIRE, GUIDE, CATHETER

Model Number	TW*DS430FH
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: requested, not provided, age & date of birth: requested, not provided, patient sex: requested, not provided, weight: requested, not provided, ethnicity: requested, not provided, race: requested, not provided, lot number: requested, not provided, expiration date: unknown due to unknown lot number, implanted date: device was not implanted, explanted date: device was not explanted, device manufacture date: unknown due to unknown lot number.The actual samples finecross mg and runthrough ns were received for evaluation.They were in the state of being combined with each other.Visual inspection revealed that the actual finecross mg sample (the catheter) and the actual runthrough ns sample (the guide wire) in the combined state: the distal 912mm of the guide wire was protruding from the catheter; the outer layer of the catheter had been ruptured and the reinforcing wire was exposed on the area approximately 184mm-619mm from the distal end of the catheter; the guide wire was trapped in the catheter; removing the guidewire from the catheter was not possible.Magnifying inspection of the catheter found that the outer layer had been elongated on the area approximately 10mm-184mm and 619mm-640mm from the distal end.Some scratches were observed on approximately 30mm from the distal end.X-ray fluoroscopic inspection of the catheter revealed that the reinforcing wire had been elongated in the area approximately 160mm-600mm from the distal end.No obstruction was observed in the lumen.Magnifying inspection of the guide wire found that platinum coil pitch had been widened near the joint of platinum coil, stainless steel coil, and niti core wire.Magnifying inspection of the guide wire did not find any anomaly such as widened coil pitch in the stainless-steel coil section.Magnifying inspection of the shaft of the guide wire found that the ptfe coating had been exfoliated in the area approximately 720mm-912mm from the distal end.Magnifying inspection of the exfoliated damaged section on the ptfe coating revealed some abrasions on the surface, and that the exfoliation had developed in the proximal direction.Based on this, it is likely that the guide wire may have been exposed to a hard object while it was manipulated forward.The intact section of the guide wire was split lengthwise to see the adhesion state of the ptfe coating.No gap was observed under the coating layer.The outer diameter of the catheter and the guide were measured and confirmed to meet the manufacturer specifications.Reproductive testing was performed.Reproduction of the rupture of the outer layer on the actual catheter sample: the distal end of a finecross mg test sample combined with a runthrough ns test sample was trapped, and then exposed to pulling force.As a result, the outer layer was elongated and ruptured, which caused the reinforcing wire to be exposed.Reproduction of the exfoliation of ptfe coating on the actual guide wire sample: a runthrough ns test sample was inserted in a metal inserter, and then manipulated in a manner that the shaft could contact the tip of inserter.As a result, ptfe coating was exfoliated.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.Record review of the catheter: 35-1450(nc*f865a)/190618 a review of the device history record and the product release decision control sheet of the product code/lot# combination was conducted with no findings.Udi no.: (b)(4).Ifu states: carefully handle the product under high resolution fluoroscopy.If any resistance is felt while handling the product, immediately stop the manipulation and find out cause of the resistance in order to avoid damage to blood vessels and separation or breakage of the product.Do not manipulate and/or withdraw the runthrough ns through a metal entry needle, a metal dilator, or a metal guide wire inserter.Manipulation and/or withdrawal through a metal entry needle, a metal dilator, or a metal guide wire inserter may result in destruction and/or separation of the runthrough ns.Do not use the runthrough ns with devices which contain metal parts such as atherectomy catheters.Such manipulations may cause the runthrough ns hydrophilic polymer coating to peel off, and damage and/or sever the wire.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.As a possible cause of the ruptured outer layer of the actual catheter sample, it was likely that the catheter with its distal end being trapped was subjected to pulling force in the withdrawal direction.As a result, the shaft became elongated and lumen became narrowed, resulting in causing the actual guide wire sample to be stuck inside.It is likely that the actual guide wire was manipulated forward while the shaft was exposed to a hard object, resulting in the exfoliation of ptfe coating.However, the exact cause of the reported event cannot be definitively determined based on the available information.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 or Problem Description
The user facility reported that the involved finecross was used off label in the at to cross.Once down in the pedal arch, the doctor wanted to pull the hypercoat out, to exchange for viper wire so threy could spin.However, the hypercoat would not come back.The finecross and hypercoat were taken out of patient.On the back table the tech pulled on the hypercoat and the finecross broke/sheared in the middle.The patient's condition was stable.They have to bring the patient back, as they could not cross again.There was no patient injury, medical/surgical intervention required.Additional information was received on 18oct2020.The hypercoat would not pull out the finecross while in the patient, at that point, the doctor pulled the whole system out, once on the back table, the tech pulled on the hypercoat and finecross broke apart.After evaluation of the actual sample on 10mar2020, terumo revised the reportability of the reported event as it was confirmed that the guide wire stuck in it was run through ns hyper coat.

• Brand Name: RUNTHROUGH NS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9896967
• Report Number: 9681834-2020-00046
• Device Sequence Number: 19534983
• Product Code: DQX
• UDI-Device Identifier: 04987350721006
• UDI-Public: 04987350721006
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2020

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
• Operator of Device: Health Professional
• Device Model Number: TW*DS430FH
• Device Catalogue Number: 25-3013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1