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

Model Number	N/A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2018
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 section.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 a 11f portico solopath was used for a portico implant.But they were unable to re-collapse the portico solo for removal after the successfully implantation of a 25mm portico valve.So the physician removed it directly.The patient was reported to be stable.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update the device evaluated by mfr and to provide the completed investigation results.One 19 fr solopath device was received for product evaluation.During decontamination, a reaction with the solution occurred within the sheath indicating the sheath may have been submerged in another substance such as bleach before the reception at terumo medical corporation.Visual inspection revealed that the sheath contained spots of black residue from the reaction.No gross anomalies were 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 noted at approximately 0.647" from the hub.Microscopy revealed that the section in the outer jacket had a small hole present.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the leak might be the presence of plaque/calcium in the artery.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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: 8166269
• Report Number: 1118880-2018-00192
• Device Sequence Number: 2112738
• Product Code: DYB
• UDI-Device Identifier: 15415067028157
• UDI-Public: 15415067028157
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K152498
• 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
• Report Date (Section B): 12/14/2018

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: 12/31/2018
• Device Model Number: N/A
• Device Catalogue Number: PRTSOLO-19
• Device Lot Number: VC27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1