MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL ACCESS SYSTEM; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 19fr stfi solopath device was received for product evaluation.The device was returned mated with the dilator.Visual inspection revealed that the sheath appeared to be in its original folding pattern indicating that the sheath was not inflated.The fairing tip at the end of the dilator appeared to be slightly dislodged from its original manufacturing position.No other anomalies were noted on the returned device.Functional testing was not possible due to the tip dislodgement.Microscopic inspection of the dilator tip revealed that the tip was slightly dislodged.A review of the device history record of the product code/lot# combination was conducted with no findings.Terumo has determined the reported event to be manufacturing related, and is being further investigated.This report is for the first device reported, for the second device reported during the same procedure see mdr 1118880-2019-00087.
Event or Problem Description
The user facility reported that the solopath device was damaged when they took the solopath out of the package.The silicone was still connected with the sheath; however, there was too little silicone covering the distally part of the sheath.There were some sharp edges at the transition of the sheath/tip.The doctor took another solopath, which also had the same issue.There was no patient involvement; the event occurred before use.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the reporting number.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the assigned res number 82705.Has not yet been provided; however a follow up will be submitted, once the reporting number has been assigned.

• Brand Name: SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL ACCESS SYSTEM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8518337
• Report Number: 1118880-2019-00086
• Device Sequence Number: 11088626
• Product Code: DYB
• UDI-Device Identifier: 00852381004265
• UDI-Public: 00852381004265
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K100819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2019

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: STFI-1925
• Device Lot Number: VM24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 04/29/2019; 05/29/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/14/2019; 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1374-2019
• Patient Sequence Number: 1