MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	RF*XL9510GA
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/19/2018
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 was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.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 that when the catheter was removed from the patient the tip appeared to be sheared off when using the glidecath device.A follow-up ct scan was performed and the tip of the catheter was found to be in the left sfa (superficial femoral artery).The patient was transferred to interventional radiology where the foreign object was successfully retrieved.It was reported that the patient is healthy.The procedure outcome was a success.Additional information was received on 7/20/18.The procedure performed was a distal renal angiography.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1.Attached the received user facility medwatch (b)(4).Attachment: [uf mw (b)(4).Pdf].
Event or Problem Description
Terumo medical received user facility medwatch report no.(b)(4) on september 26, 2018 that reported the following.During an angiogram of the right lower extremity, a glide catheter was passed from the femoral artery, up the left lower extremity to deliver the contrast injection.The catheter was removed at the end of the case.On repeat imaging several days later, a retained catheter fragment was observed in the left popliteal artery.This required removal by interventional radiology.The patient has undergone repeated duplex imaging which has demonstrated healing of the artery.The original intended procedure was a lower extremity angiography.

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 7746686
• Report Number: 9681834-2018-00177
• Device Sequence Number: 11077219
• Product Code: DQO
• UDI-Device Identifier: 04987350772459
• UDI-Public: 04987350772459
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K915414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2018

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 Model Number: RF*XL9510GA
• Device Catalogue Number: CG507
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 09/28/2018
• 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: GLIDECATH; GLIDEWIRE; PINNACLE SHEATH; GLIDECATH; GLIDEWIRE; PINNACLE SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 82