MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA GLIDESHEATH SLENDER; INTRODUCER CATHETER

Catalog Number	RM*ES6J10HAT
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: udi- unknown due to unknown lot number, however, the di portion is provided.The actual device has not been returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, evaluation code 20 has been referenced in the conclusions section of h6.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 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.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.H3 other text : device has not been received.
Event or Problem Description
The user facility reported the coating sheared off with the involved glidesheath slender device.The following information was provided by the user facility: the plastic jacket wire was put into a metal needle by the physician in the femoral artery; part of the coating sheared off the wire; a snare was used to retrieve the sheared off coating; the procedure outcome was good; and it was reported that the patient's condition was good.Additional informaiton was received on (b)(6) 2017.All pieces of the sheered product was recovered and the patient was fine.
Additional Manufacturer Narrative
The report is being submitted as follow-up no.1 to provide the completed investigation results.It was initially reported that the device was available for evaluation, however, the device is no longer available for evaluation.Sections have been updated to reflect that the device was not returned or evaluated.With no return of the actual device, the root cause could not be determined.Based on the reported event description, it is likely that the actual sample was withdrawn from a metallic needle in the state where the actual sample had contact with the needle, resulting in the reported event.The device labeling does address the potential for such an event in the instruction for use (ifu) with the statement such as the following: "do not use a plastic guide wire with the metallic entry needle.Withdrawing the plastic wire through the metallic entry needle or advancing the entry needle over the plastic wire may cause the plastic part to shear, that may necessitate retrieval." all available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to correct the udi no.That was reported in the initial report.The udi was initially reported as (b)(4), the correct udi no.Is (b)(4).

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 6585411
• Report Number: 9681834-2017-00110
• Device Sequence Number: 624131
• Product Code: DYB
• UDI-Device Identifier: 04987350717986
• UDI-Public: 04987350717986
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K142183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2017

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 Catalogue Number: RM*ES6J10HAT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 06/23/2017; 10/25/2017
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 07/17/2017; 11/07/2017
• 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: METAL 18G NEEDLE; METAL 18G NEEDLE
• Outcome Attributed to Adverse Event: Required Intervention