MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GUIDEWIRE M; WIRE, GUIDE, CATHETER

Model Number	RF*GA18153A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: 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.For this reason, evaluation code 11 has been referenced in the conclusions section of h6.A review of the device history record and shipping inspection record of the involved product code/lot# combination was conducted with no findings.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.
Event or Problem Description
The user facility reported breakage on the involved rf guidewire device.The procedure was a perma cath insertion, utilizing the right internal jugular, which was very tortuous.Access was obtained with a micropuncture kit and introducer 5fr, glidewire utilized via the micropuncture sheath introducer, not the access needle.It was noted and appeared the glidewire tip fractured, with the tip remaining in the external jugular vein, coiled, very tortuous tiny vein, suspecting probably intima (the innermost coating of a vein or artery).It was reported that the doctor choose not to intervene at this time for retrieval of tip.The patient was reported to be "ok".It was reported that the permachath insertion was successful.
Event or Problem Description
Additional information was received on 7/12/18.The location of the device was detected by fluoroscopy.The patient appears to be very stable.The patient has been seen and the patient has been imaged since the occurrence, in placing additional trialysis catheters and perma catheters.No further complications noted or reported at this time.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional event information in event, provide the device return date in concomitant medical products, and provide the completed investigation results.Ethnicity: requested, not provided.The actual device has been returned for evaluation.Visual inspection upon receipt revealed that the urethane outer layer had been peeled off on approximately 55 -124mm from the distal end of the device, where the core wire was noted to have been exposed.The urethane outer layer-peeled segment was inspected under magnification and revealed the following.The urethane outer layer sheared off the core wire had been rolled back over the wire in the distal direction.The edge of the peeled urethane outer layer presented the configuration which.The length of the rolled back portion of the urethane outer layer was approximately 38mm.Whereas the length of the exposed core wire was approximately 69mm.From this, it is likely that a portion of the urethane outer layer approximately 31mm in length is missing.The outside diameter of the shaft was measured on the undamaged segment and confirmed to meet manufacturer specifications.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause of the reported event cannot be definitively determined based on the investigation, it is likely that in the state of being combined with the involved device, the actual sample had contact with a hard object, including the hard distal tip of the involved device and the surface of the urethane outer layer became damaged and lifted from the core wire.Subsequently, when the actual sample was being withdrawn, the lifted part of the urethane outer layer was caught in the distal end of the involved device, pulled and peeled in the distal direction, resulting in its rollback over the shaft.However, with no evaluation of the device used in combination with the actual sample, it is difficult to definitively determined.The ifu states: "if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire and/or the catheter and determine the cause by fluoroscopy.Failure to exercise proper caution may result in bending, kinking separation of the guide wire's tip, damage to the catheter, or damage to the vessel.".

• Brand Name: RADIFOCUS GUIDEWIRE M
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 7642642
• Report Number: 9681834-2018-00116
• Device Sequence Number: 1781677
• Product Code: DQX
• UDI-Device Identifier: 04987350772855
• UDI-Public: 04987350772855
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K863138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2018

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: RF*GA18153A
• Device Catalogue Number: GR1805
• Device Lot Number: 180220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Weight: 100