MAUDE Adverse Event Report: OSCOR INC. DESTINO REACH 12F STEERABLE GUIDING SHEATH; INTRODUCER, CATHERTER

Model Number	DCR1207122
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A preliminary review showed there were no manufacturing rejects or anomalies of this event type recorded in the device history record.Conclusion not yet available as although the product has been received, the investigation is on-going and not yet completed.
Event or Problem Description
During an afib cryo procedure on (b)(6) 2018 it was reported that there were issues with two destino reach 12f steerable guiding sheaths.The physician mentioned that the first reach steering mechanism went out after accessing the third vein.The sheath stopped deflecting when the handle was twisted.The second reach, same lot number, snapped after it was inserted.This second reach had been tested outside the patient prior to procedure and it had worked with no issue observed.A third reach steerable guiding sheath was available and worked without incident.The procedure was completed and no cause for concern or injury to the patient was reported.Additional information was requested but has not been received.The products in question have been returned and are in process of evaluation.
Additional Manufacturer Narrative
Reassessed as not reportable.Upon review of reported event , it has been determined that reported device failure (malfunction) has not caused or contributed to serious injuries and death.Initial report was submitted in error so please void it.

• Brand Name: DESTINO REACH 12F STEERABLE GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHERTER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 7466831
• Report Number: 1035166-2018-00037
• Device Sequence Number: 18860095
• Product Code: DYB
• UDI-Device Identifier: 00885672007430
• UDI-Public: 00885672007430
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K151951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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: Physician
• Device Expiration Date: 11/01/2020
• Device Model Number: DCR1207122
• Device Catalogue Number: DCR1207122
• Device Lot Number: C8-11721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 09/25/2018
• Patient Sequence Number: 1