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

Catalog Number	STFI-1935
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number for this product code was not reported, therefore only the di portion has been provided.The actual sample was not available for evaluation.Therefore, the investigation was based upon the user facility information as well as a photo of the used device.Evaluation of the product photo confirmed the sheath to be broken in multiple pieces.A device was noticed to be inserted through the sheath.There were 3 broken pieces of the sheath, however the photo of the distal segment of the sheath was not available.All the broken segments of the sheath were observed to have evidence of stretching and exposed metal coil.The production lot number was not provided by the user facility which prevented a meaningful review of production and complaint records.Product specific trending for the past three years shows there have been no similar reports.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause of the reported event cannot be definitively determined based on the available information, it is likely that the sheath may have been caught on the large calcium burden resulting in the difficult sheath removal and eventual sheath breakage due to increased removal force.The device labeling does address the potential for such an event in the instructions-for-use (ifu), with statements 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.
Event or Problem Description
The user facility reported that the valve of the solopath disconnected from the sheath.Follow up communication with the user facility confirmed the following information: during a fem pop surgery an edwards sapien 3 23 valve was inserted into the solopath sheath; the valve then became stuck proximal to mid sheath; it was stated that the solopath was observed on x-ray fully expanding; the iliac was reported to be heavily calcified and to have a significant lesion; once the valve was stuck, it was decided to remove everything, sheath included; the sheath was then stuck as well; after pulling on the sheath, the valve of the solopath became disconnected from the sheath; a cut down was performed and the solopath along with the edwards valve was removed the rest of the way causing a complete evulsion of the artery; a vascular bypass was performed for repair; the initial procedure was aborted; blood loss was less than 250 cc; and the patient was reported as in stable condition.

• Brand Name: SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL ACCESS SYSTEM
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): ONSET MEDICAL CORPORATION; 13900 alton parkway; suite 120; irvine CA 92618
• MDR Report Key: 6292873
• Report Number: 3004672932-2017-00001
• Device Sequence Number: 13684277
• Product Code: DYB
• UDI-Device Identifier: 00852381004272
• UDI-Public: 00852381004272
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2017

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 Catalogue Number: STFI-1935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2017
• Initial Report FDA Received Date: 02/01/2017
• 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: EDWARDS SAPIEN 3 23 VALVE
• Outcome Attributed to Adverse Event: Other; Required Intervention