MAUDE Adverse Event Report: OSCOR INC. DESTINO TWIST STEERABLE GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	DCT1357125NM
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation is still in progress ,follow up report will be submitted if we find any further additional information.
Event or Problem Description
It was reported that during atrial fibrillation ablation procedure sheath valve was leaking.No additional information is available and no patient side effects reported.
Additional Manufacturer Narrative
The device was used for treatment.One 13.5f destino twist was returned from the customer with the dilator.There were no other accessories.Blood was found on and inside the sheath and dilator.There was an identification sticker on the handle of the sheath upon receipt of the product.Upon evaluation of the returned product, the hemostasis valve was found to be completely intact, looked normal and there were no splits found down the sheath tube.No leakage was found when manually leak tested at the site where the sideport tubing and stopcock attaches to the hub.The introducer was then tested using the iso standard liquid leakage test.The device was connected at the distal tip and pressurized to 38kpa and then examined for liquid leakage.The part passed the leak test.The part was then pressurized to over 300kpa for 30 seconds and held pressure for the 30 second duration.The part passed per the iso standard.Returned device analysis revealed the sheath is within manufacturing specifications.The reason for return cannot be confirmed.No manufacturing defects were found.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Per procedure destino steerable guiding sheath in-process and final inspection: leak test: perform leak test according to procedure.The leak test is performed by manufacturing personnel and is observed by quality assurance personnel.This procedure is performed on 100% of the sheaths.Per ifu: the steerable sheath must be thoroughly flushed with either saline or heparinized saline and free of air prior to use to avoid air embolism to the patient.Wet the dilator shaft with sterile saline solution prior to insertion through the hemostatic valve.Note: any device/component inserted through the hemostatic valve of the sheath should be wet and placed through the center of the valve to prevent tearing of the seal and leakage.Based on the investigation, a capa is not required as there were no design, labeling or manufacturing related non-conformity found.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.Oscor inc.Is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report is based upon information obtained by oscor inc.Which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, oscor inc., or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, oscor inc., or its employees, that the report constitutes an admission that the device, oscor inc., or its employees caused or contributed to the event described in this report.

• Brand Name: DESTINO TWIST STEERABLE GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm habror FL 34683
• MDR Report Key: 9207705
• Report Number: 1035166-2019-00085
• Device Sequence Number: 16902085
• Product Code: DYB
• UDI-Device Identifier: 00885672008819
• UDI-Public: 00885672008819
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: DCT1357125NM
• Device Catalogue Number: DCT1357125NM
• Device Lot Number: C8-15474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1