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	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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 that the solopath was used for an abdominal aortic aneurysm (aaa) procedure.The solopath was placed in the left groin through a cut down access.It expanded successfully and the appropriate therapeutic devices were advanced through the sheath.When it was time to collapse the solopath, the physician attached an inflation device to the collapsible port and started to inflate to 6atm.The physician noticed it was taking some time to get to 6atm.The physician ended up using fluoroscopy and noticed a pooling of contrast.The physician was able to remove the solopath without problem and believed the cause of the collapsible balloon was due to the plaque/calcium of the artery.The procedure was completed successfully.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update and to provide the completed investigation.One 19fr solopath device was received for product analysis.The 25 cm sheath was returned separated from the balloon dilator.Visual inspection revealed that the balloon dilator was returned in a curved configuration.There were no other gross visual anomalies noted with the balloon dilator.Under visual examination, the sheath appeared collapsed.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 measured approximately 2.4990" from the distal tip.Microscopy revealed the section in the outer jacket where a small pin hole was present.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, the physician stating he believed the cause was the plaque/calcium present in the artery, and past complaint history; it is likely that reported damage could have resulted from difficult anatomical conditions such as calcium depositions or previous stents 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: 8009042
• Report Number: 1118880-2018-00155
• Device Sequence Number: 10805414
• Product Code: DYB
• UDI-Device Identifier: 00852381004340
• UDI-Public: 00852381004340
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2018

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: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: SR-1925
• Device Lot Number: VH21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1