MAUDE Adverse Event Report: OSCOR INC. ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F; INTRODUCER, CATHETER

Model Number	990061-055
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is undergoing an evaluation but has not yet been completed.
Event or Problem Description
It was reported that following transseptal puncture, the brockenbrough needle and arrive sheath were removed and flushed on the table.A piece of lining from the sheath was flushed out.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
It is unknown if the device was used for diagnostic or treatment purposes.Device analysis reveals a 10f sheath and dilator within manufacturing specifications.A review of the device history record (dhr) identified no rejects during manufacture of this lot number.A review of complaints against this lot number identified no additional reports.The returned dilator was reviewed and was shown to meet all design specifications.When bisected, the returned dilator showed evidence of slight skiving on the shaft.Testing has shown that the transseptal needle, in combination with the dilator is potentially susceptible to skiving.No patient injuries were reported with this complaint.Additional investigation testing has shown that the transseptal needle, in combination with the dilator is potentially susceptible to skiving.This testing demonstrates that the risk of sikiving is possible with a range of transseptal needle types.Additional testing was conducted to assess possible design changes for the arrive dilator along with testing competitor dilators used for transseptal procedures.All proposed product designs and competitor dilators demonstrated the susceptibility to skiving.This testing demonstrates that no changes could be made to the arrive dilator to further mitigate the risk of skiving.Per the arrive sheath clinical evidence report (cer), the clinical evaluation of the sheath and dilator demonstrate the clinical safety and performance of the device.The outputs of the risk management process, the device-body interaction, and clinical performance of the device demonstrate that the benefit to the patient is greater than any risk identified.The reason for return was confirmed, however, no manufacturing defects were found.The conclusion of the investigation has determined the rate of skiving reports is acceptable, the risk is known, and no patient harm has been reported.However, a capa was opened to investigate the root cause, and implement corrective action to prevent recurrence of the reported failure.Per the qa adelante breezeway dilator in-process and final inspection procedure, a blunt ts inspection mandrel is used for insertion into the dilator shaft to check for patency on 100 percent of the dilators.The arrive sheath instructions for use (ifu) instructs when "preparing and managing the transseptal sheath, if a transseptal needle is used, it is recommended to use together with a stylet in order to prevent skiving of the inner lumen of the dilator.".

• Brand Name: ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 6107295
• Report Number: 1035166-2016-00172
• Device Sequence Number: 13554988
• Product Code: DYB
• UDI-Device Identifier: 00643169530584
• UDI-Public: 00643169530584
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K122958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2017

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: Physician
• Device Expiration Date: 07/01/2019
• Device Model Number: 990061-055
• Device Catalogue Number: 990061-055
• Device Lot Number: C1-12665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/21/2016
• Supplement Date Received by Manufacturer: 10/21/2016
• Initial Report FDA Received Date: 11/16/2016
• Supplement Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT APPLICABLE
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BROCKENBROUGH NEEDLE