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

Model Number	TW*AS430XA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and the product release decision control sheet of the involved product code/lot# combination was conducted with no findings.This report is for the first device reported, for the second device reported that was used on the same patient see mdr 9681834-2019-00148.(b)(4).For importer report, see mdr 2243441-2019-00067.
Event or Problem Description
The user facility reported that the doctor was doing a complex coronary, involving in-stent restenosis and laser atherectomy.He used 2 runthrough wires and both had part of the distal wire break off and stay in the patient.They tried to snare the pieces unsuccessfully.The patient condition was stable at the end of the procedure.There was no surgery; however, they were unable to remove the wire with snare.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.Visual inspection revealed that the niti core wire and the platinum coil had been fractured at the distal end of the device.The niti core wire located inside the platinum coil was found to be approximately 15mm in length.Compared with that of a factory-retained sample of the same product code, which was approximately 30mm in length, the niti core wire of the actual sample was confirmed to have been missing approximately 15mm in length.Magnifying inspection of the platinum coil segment located proximal to the fracture end found that the platinum coil had been raveled on the segment 0mm - the joint of the platinum coil, stainless steel coil and the niti core wire.Due to the raveling, the length of the missing portion of the platinum coil was unknown.Magnifying inspection of the stainless-steel coil segment did not have any other anomaly, including widened coil pitch or jumbled coiling, in the appearance.Electron microscopic inspection of the fracture of niti core wire revealed the fracture end was not deformed in a curved or tapered shape.Electron microscopic inspection of the fracture cross-section of the niti core wire revealed that the dimple pattern and the radial pattern had been generated on the surface.The outer diameter of the niti core wire was measured on the segment adjacent to the fracture and confirmed to be equivalent to that measured on approx.15mm from the distal end of the factory-retained sample of the same product code.The actual sample: approximately 0.096mm; factory-retained sample: approximately 0.096mm; outer diameter of the stainless-steel coil segment was confirmed to meet the specifications.Reproductive testing was performed on four current samples from the involved product code.With their coils of being trapped at approximately 15mm from the distal end, they were subjected to the below-mentioned force respectively until their niti core wires located under the platinum coils became fractured and the platinum coils became raveled.Then the fracture state of niti core wire of each test sample was observed under electron microscope and compared with that of the actual sample.Pulling force: the fracture end had been deformed in a tapered shape, though dimple pattern was seen on the fracture cross-section surface.This state was found to be different from that of the actual sample.Continuous torque force: trace of having been subjected to torsional force was seen on the lateral surface of the wire though the dimple pattern was seen on the fracture cross-section surface.This state was found to be different from that of the actual sample.Bending force: the niti core wire shaft had been curved on the area adjacent to the fracture, and the dimple pattern and radial pattern were seen on the fracture cross-section surface.This state was found to be similar to that of the actual sample.Pulling force to the test sample held in the loop shape.The distal end of the niti core wire had been deformed in a hook shape.The dimple patterns and a trace of having been subjected to torsional force were observed on the fracture cross- section surface.This state was found to be different from that of the actual sample.Ifu states: manipulate the runthrough ns carefully when crossing it through a deployed stent.Stent migration, stent deformation, or breakage or separation of the runthrough ns may be caused if the runthrough ns is caught by the deployed stent.If any resistance to the runthrough ns or the dilatation catheter is felt during manipulation or if the shape, behavior or position of the guide wire's tip seems improper, e.G., in case where the tip is trapped due to vessel spasm or some other cause or the tip is trapped due to vessel spasm or some other cause or the tip is folded, stop manipulating the guide wire (and the catheter) and determine the cause carefully by fluoroscopy and take suitable remedial actions.Then remove the guide wire slowly, without turning, to exchange it for a new one.Continuing guide wire or catheter manipulation in the said situations may result in damage to the vessel, damage to or separation of the guide wire's tip, and/or damage to the dilatation catheter.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 distal segment of the actual sample was trapped in some hard object, e.G.In-stent restenosis.In attempts to release the trap, excessive bending force was applied to the actual sample, resulting in the generation of the fracture on the niti core wire located inside the platinum coil; during further withdrawal manipulation, the platinum coil was raveled and fractured.However, the exact cause of the reported event cannot be definitively determined based on the available information.
Additional Manufacturer Narrative
The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.
Event or Problem Description
Additional information was received on 02aug2019.After reviewing the images (lab manager and company representative), it was believed that only the first wire broke into two parts.The progression of the procedure: rotoblader (boston scientific) the left main, there was a stenosed stent in the ramus, advanced runthrough (lot 170420) through stent, lasered (philips), wire was prolapsed, angioplasty of stent, when wire was removed, distal part of wire remained (approximately 26mm), in the images, a second radiopaque portion of the wire distal to the stent; however, proximal to the left behind wire was seen.The physician advanced a second runthrough wire and attempted to snare; unsuccessfully.When removing the second wire, they thought a 10mm portion broke off; however, they now think it was also part of the first wire.The patient condition was continuing to be stable with wire fragments remaining implanted; the location of the wire fragments is in the patient's ramus.Approximate size of wire fragments - distal 26mm, proximal segment 6mm.There was no further medical or surgical intervention taken place.Additional information was received on 26sep2019.The patient's condition continued to be stable.

• 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: 8896314
• Report Number: 9681834-2019-00147
• Device Sequence Number: 240878
• Product Code: DQX
• UDI-Device Identifier: 04987350703583
• UDI-Public: 04987350703583
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: TW*AS430XA
• Device Catalogue Number: 25-1013
• Device Lot Number: 170420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 08/02/2019; 09/09/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/30/2019; 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LASER ATHERECTOMY; LASERED (PHILIPS); ROTOBLADER BOSTON SCIENTIFIC; LASER ATHERECTOMY
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Weight: 71