MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION SOLO PATH RE-COLLAPSIBLE ACCESS SYSTEM; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, evaluation code has been referenced in the conclusions.A review of the device history record of the product code/lot# combination was conducted with no findings.This report is for the device that was reported to leak blood from the solopath device.See mdr 1118880-2018-00055 for the contrast that was reported to be leaking from a hole in the external solopath balloon device that was used on the same patient.
Event or Problem Description
The user facility reported that during a tevar case with left cfa access using solopath device the physician attempted to inflate the deflation balloon and all of the contrast was noted to be leaking from a hole in the external solopath balloon.The physician forced a rapid bolus of contrast which was able to get pressure to 6atm which did collapse the solopath before removal.It was also noted that after the dilator was removed from the solopath and a wire was in place, the solopath leaked blood, at times being a pulsatile stream.Blood loss was reported to be less than 250cc.The patient is fine and stable.The procedure was completed successfully.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.One 24 fr solopath device was returned for evaluation.The 35 cm sheath was returned with the balloon dilator.The balloon dilator was returned not inserted into the sheath.Visual inspection revealed no anomalies on the balloon dilator.The sheath was partially collapsed at the distal tip.The valve was tightly mated with the sheath.No gross visual anomalies were noted.Functional testing was conducted by clamping the distal end of the sheath.Water was then injected into the sheath from the side tubing.When 2ccs of water were injected, water then began leaking of the hemostatic sheath.The valve was then dissected to observe if the cause of the leakage could be identified.No issues were noted with the first two silicone plugs.The crosscut hemostatic valve was then examined.There was an incomplete seal between two of the valve flaps.Additionally, there was clotted blood present.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information.
Event or Problem Description
Additional information was received on 8/8/18.An 0.035" 180cm stiff angled glidewire was used during the procedure.Additionally, the patient had heavily calcified arteries.

• Brand Name: SOLO PATH RE-COLLAPSIBLE ACCESS SYSTEM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 7537572
• Report Number: 1118880-2018-00056
• Device Sequence Number: 2018872
• Product Code: DYB
• UDI-Device Identifier: 00852381004418
• UDI-Public: 00852381004418
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K121404
• 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,Followup,Followup
• Report Date (Section B): 05/23/2018

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: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: SR-2435
• Device Lot Number: VG09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 06/21/2018; 08/08/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 06/25/2018; 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 62