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

Catalog Number	STFI-1435
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi no.- the udi number for this product code/lot number combination is not required.The di portion has been provided.The actual device was returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent.For this reason (b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Event or Problem Description
The user facility reported that the solopath device broke during a procedure.Follow up communication with the user facility confirmed the following information: a 14fr x 35 cm solopath sheath was used for an evar procedure using an endologix graft; the patient had 4 mm iliac vessels with highly calcified lesions and previously deployed stents present; the vascular surgeon pre-dilated the external and common iliac vessels with an 8 mm followed by a 10 mm and then a 12 mm balloon prior to placing the sheath; the solopath sheath was then introduced and inflated without incident; the procedure was completed and the aaa graft was placed successfully; when it came time to remove the solopath sheath, it would not move; the surgeon pulled very aggressively until the sheath broke around mid-shaft of the sheath, leaving the distal half in the vessel; the surgeon was able to remove a few more segments of the sheath via a cut down but was unable to remove all the remaining segments; the vascular surgeon left the remaining distal portion of the sheath in the patient as it was unable to be retrieved, the surgeon felt it did not pose a threat to the patient's health; blood loss was less than 250 cc; and the patient was reported as stable and recovering.
Additional Manufacturer Narrative
This report is being submitted as follow up number 1 to provide the sample evaluation results as well as to provide the udi number.The proximal portion of the broken sheath was received for evaluation along with 3 other broken pieces of the sheath.Visual examination revealed the sheath to be completely flattened on the expandable portion of the sheath.It was folded/kinked at about 11 cm from the distal end of the hub.The kink was assumed to have happened during sample return based on the status of the sample upon return.The sample was noticed to be stretched at the broken end with exposed metal coils.In addition, three broken pieces were also noticed to be stretched with exposed metal coils.The retention samples form the reported and subsequent lots were subjected to visual examination.The visual examination revealed no visual defects on the sheath.A review of the device history record of the product code/lot # combination was conducted with no relevant findings.A search of the complaint file did not find any other report with the involved product code/lot # combination.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, it is likely that the excessive removal force used when the sheath becoming stuck on the large calcium burden resulted in reported event.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with states such as the following: "if resistance is met when advancing or withdrawing the guidewire or sheath, determine the cause by fluoroscopy and correct before continuing with the procedure".All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• 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: 6176640
• Report Number: 3004672932-2016-00013
• Device Sequence Number: 18924481
• Product Code: DYB
• UDI-Device Identifier: 00852381004210
• UDI-Public: 00852381004210
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K100819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: STFI-1435
• Device Lot Number: UG22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 01/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOONS; ENDOLOGIX GRAFT
• Outcome Attributed to Adverse Event: Other; Required Intervention