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 second device reported, for the first device reported that was used on the same patient see mdr 9681834-2019-00147.(b)(4).For importer report, see mdr 2243441-2019-00068.
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 provide the completed investigation results.The involved device was not returned for evaluation.Therefore, the investigation was based on user facility information and evaluation of the retention sample.Visual inspection revealed no obvious anomalies, such as a kink or fracture, in the appearance along the total length.Magnifying inspection of the platinum coil segment did not find any anomaly, such as a deformity or jumbling on the coil.Magnifying inspection of the stainless-steel coil segment did not find any anomaly, such as a deformity or jumbling on the coil.The outside diameter on the coiled segment was measured and confirmed to meet the specifications.Magnifying inspection of the uncoiled segment confirmed it did not have any anomaly.The ptfe coating was confirmed to be intact.The shipping inspection record was viewed, being focused on the fracture resistance of the distal tip.No deviation was noted in the result.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.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 pulling or torqueing force might have been applied to the actual sample, resulting in the fracture of the core wire.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in section b5 and d11.It was confirmed that the actual device is not available; therefore, sections d10 and h3 have been updated.The actual device was not 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: 8896319
• Report Number: 9681834-2019-00148
• Device Sequence Number: 1617898
• 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: 01/31/2020
• Device Model Number: TW*AS430XA
• Device Catalogue Number: 25-1013
• Device Lot Number: 170221
• Was Device Available for Evaluation?: No
• 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