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

Model Number	CG508
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device was not returned to the manufacturer facility for evaluation.No evaluation could be conducted due to the device not being returned.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.There is no evidence that this event was related to a device defect or malfunction.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record, shipping inspection record and complaint files.Terumo medical product (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Event or Problem Description
The user facility reported that the 20 x 39 mmm cx was passed through a 5fr 100 glidecath during a type 2 endoleak that was being treated through transcaval access.The coil was being fed through the catheter and resistance was felt.Most of the coil was out of the catheter until they could no longer push the coil or retract it.The physicians tried to push the coil out with multiple wires and were unsuccessful.The catheter was then removed and a snare was used to pull the coil out - which part of the coil appeared to have made it out of the aortic sac into the vena cava.The patient was fine and already had a coil deployed into the endoleak.It was reported that the patient was stable.The procedure outcome was reported to be successful.Additional information was received on 10/4/2017.The glidecath appeared to have backed up and looped a little bit which may have been strain from the sheath but there was no confirmed kink.No subsequent coils were delivered as the entire system had to be removed.The coil appeared frayed and when it was pulled out by snare it was visibly damaged.

• 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: 6979351
• Report Number: 9681834-2017-00233
• Device Sequence Number: 10884586
• Product Code: DQO
• UDI-Device Identifier: 04987350772473
• UDI-Public: 04987350772473
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

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: CG508
• Device Catalogue Number: RF*XL95110A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 10/26/2017
• 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: AZUR COILS; AZUR COILS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Weight: 85