MAUDE Adverse Event Report: ONSET MEDICAL CORPORATION SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM, INTRODUCER; INTRODUCER CATHETER

Catalog Number	SR-1935
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The udi number for this product code/lot number combination is not required.The di portion has been provided.The actual device was not available for evaluation.Therefore, the failure investigation was limited to assessment of information provided by the user facility and quality documents.A review of the device history record of the involved product/lot# combination was conducted with no relevant findings.A search of the complaint file did not find any other report with the involved product/lot combination.There is no evidence that this event was related to a device defect or malfunction.Although the cause of the reported event cannot be definitively determined, the event description provided by the user facility indicates that a potential root cause for the difficult sheath removal may have been related to the sheath being stuck on a calcium burden or in difficult anatomy.The device labeling does address the potential for such an event in the instructions-for-use, which states: "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.
Event or Problem Description
The user facility reported that the solopath device was difficult to remove from the patient during a case.Follow up communication with the user facility confirmed the following information: preparing for tabr, patient had small iliac approximately 4.5mm; slight calcification except at the bifurcation where moderate calcification was noted; three dilators in incremental size were used to pre-dilate prior to attempting to insert the evolute core valve device; able to pass the device and when it was retrieved it was noted to have some intima on the device; when the device was removed, a solopath was then placed and inflated per protocol; the core valve was cleaned off and re-inserted; it still would not pass through the iliac; after several attempts the core valve was removed; the solopath was deflated per protocol and became stuck; gentle quarter turns were made and the device was removed with part of the iliac artery attached; blood loss was less than 250cc; the patient received a fem bypass; and it was reported that the patient is doing fine and will be transferred to (b)(6) for subclavian approach valve implant.

• Brand Name: SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM, INTRODUCER
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): ONSET MEDICAL CORPORATION; 13900 alton parkway; suite 120; irvine CA 92618
• MDR Report Key: 6178526
• Report Number: 3004672932-2016-00012
• Device Sequence Number: 16360102
• Product Code: DYB
• UDI-Device Identifier: 00852381004357
• UDI-Public: 00852381004357
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: 06/30/2017
• Device Catalogue Number: SR-1935
• Device Lot Number: W038787
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2016
• Initial Report FDA Received Date: 12/15/2016
• 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: EVOLUTE CORE VALVE; THREE DILATORS
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 45