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

Model Number N/A

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Pseudoaneurysm (2605)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

Patient identifier - requested, not provided.Age and date of birth - requested, not provided.Sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Expiration date - unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.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.(b)(4).

Event 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
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 7178442
• MDR Text Key: 96847188
• Report Number: 9681834-2017-00272
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 04987350718068
• UDI-Public: 04987350718068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RM*RS6F10PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other