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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: explanted date: device was not explanted the actual device was received for evaluation.Visual and magnifying inspection of the actual sample revealed the urethane outer layer had been sheared off the wire at approximately 60mm from the distal end of the device, where the core wire was exposed.The shearing of the urethane outer layer had been generated in the distal direction.The outer diameter of the shaft was measured on the undamaged segment and verified to meet the specifications.A review of the device history record and shipping inspection record of the product code/lot# combination was conducted with no findings.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation findings, it is likely that the actual sample came into contact with a hard object and the urethane outer layer got sheared off with it.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 the radifocus wire shredded.Additional information was received on june 6, 2018: the patient's condition was good.Patient access for a cardiac catheterization was being performed.The doctor had an rn open another glidesheath slender package to complete the procedure successfully.No other devices were used with this wire.The wire was shredded or nicked.Additional information was received on june 14, 2018: the reported event happened during access.The wire was not severed, and did not have any piece broken off in the patient.It was intact, however, damaged.

• 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: 7702536
• Report Number: 9681834-2018-00133
• Device Sequence Number: 18982738
• Product Code: DYB
• UDI-Device Identifier: 04987350717986
• UDI-Public: 04987350717986
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: RM*ES6F10HAU
• Device Lot Number: 180302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1