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

Model Number	N/A
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pt info: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not 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 1has been referenced in the conclusions.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported the solopath re-collapsible sr1935 balloon could not be inflated to collapse the sheath at the end of the procedure.The solopath device was removed from the patient.The balloon was checked (by inflation) once outside of the patient, and there was a leakage of the balloon in the distal part.In the iliac artery there was some calcifications that could have been the reason for the leakage.The device was removed without difficulty.There was no harm to the patient.Additional information was received on (b)(6) 2018.The size of the solopath did not match the size of the tavi device (as recommended), so the use was for other purpose during the procedure and for in service.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to update and to provide the completed investigation.One 19 fr solopath device was received for product evaluation.The 35 cm sheath was returned separated from the balloon dilator.The visual inspection of the components revealed there were no anomalies with the balloon dilator.Under visual examination, the sheath was collapsed.There were no gross anomalies noted.An inflation device filled with water, was attached to the sheath re-collapsing port.As water was injected into the outer jacket, a leak was seen at the distal tip.Microscopy revealed a small hole in the outer jacket.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely the calcification of the iliac artery was the reason for the leakage.However, 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 the device return and to update."in the age of 80" was inadvertently not included in the manufacturer narrative of the initial report.Age at the time of event: in the age of (b)(6).

• 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: 7985868
• Report Number: 1118880-2018-00148
• Device Sequence Number: 18887553
• Product Code: DYB
• UDI-Device Identifier: 00852381004357
• UDI-Public: 00852381004357
• Combination Product (Y/N): N
• Initial Reporter Country: IC
• PMA/510(K) Number: K121404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2018

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: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: SR-1935
• Device Lot Number: VL18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 10/04/2018; 12/03/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 11/28/2018; 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 80