MAUDE Adverse Event Report: OSCOR INC DIREX¿ STEERABLE SHEATH; INTRODUCER, CATHETER

Model Number	M004DS500
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
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
Catheter shaft peeling/flaking/shearing was observed.While inserting dilator into sheath customer felt normal resistance.The valve began instantly leaking blood.Physician plugged valve closed with finger and introduced the wire again.Amount of blood loss was nominal.Valve looked normal but seal obviously compromised.Different sheath was used with wire.There was surgical delay reported.No patient side effect or serious injury reported.No additional information is available.
Additional Manufacturer Narrative
The device used in treatment.One direx 12f introducer sheath was received back from the customer with the dilator.There were no other accessories.Blood was found on and inside the sheath and dilator.The pull wire was protruding out of the sheath shaft approximately 3cm from the distal tip.When tested here at oscor, slight resistance was felt when inserting the dilator into the sheath.When measured the od of the dilator and the id of the sheath was within specification.No liquid leakage was found when the sheath was manually leak tested with a syringe.The device was found to be flushing and aspirating freely without any blockage.The sheath passed iso standard of 300kpa as no leakage was observed.In relation to the wire poking out the sheath, we evaluated that the design of the product cannot produce that specific defect.The handle of destino twist is not capable of pushing the pull wire through the wall of the sheath resulting in a wire poking out the sheath.This defect could not be confirmed.Multiple attempts were made to obtain clarification of the event from the customer.As of today, no information is available.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Per qa 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: 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 findings did not identify a design, labeling or manufacturing non-conformity.In addition, there was no new failure mode identified and the risk remains acceptable.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: DIREX¿ STEERABLE SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd; palm harbor FL 34683 1816
• MDR Report Key: 9252417
• Report Number: 1035166-2019-00089
• Device Sequence Number: 1864237
• Product Code: DYB
• UDI-Device Identifier: 08714729858980
• UDI-Public: 08714729858980
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K120459
• 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): 02/04/2020

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: 04/01/2022
• Device Model Number: M004DS500
• Device Catalogue Number: M004DS500
• Device Lot Number: C8-16970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1