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

Model Number	N/A
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: explanted date: device was not explanted h4: device manufacture date - unknown due to unknown lot number the actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and the shipping inspection record of the product code/lot# combination was unable to be conducted due to the unknown lot number.The same user facility reported similar events.This report is for the first device, see mdrs: 9681834-2017-00273 and 9681834-2017-00274 for the second and third devices.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.Ifu for this product has the instructions as follows: advance or withdraw the mini guide wire slowly.If resistance is met, do not advance or withdraw the mini guide wire until the cause of resistance is determined.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 they used to use 20-1060 and switched to the slender.They believe the.021" wire in the slender kit is stiffer.They have experienced a few pseudo aneurysms in the past months and attribute it to the stiffer wire or the vasc band.All of the patients recovered and no surgery was needed.The procedure was successful.

• 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: 7178442
• Report Number: 9681834-2017-00272
• Device Sequence Number: 19157835
• Product Code: DYB
• UDI-Device Identifier: 04987350718068
• UDI-Public: 04987350718068
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2018

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: N/A
• Device Catalogue Number: RM*RS6F10PA
• 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: 12/13/2017
• Initial Report FDA Received Date: 01/10/2018
• 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