MAUDE Adverse Event Report: OSCOR INC. DESTINO REACH 8.5 STEERABLE GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	DCR0857717
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation is still in progress, follow up report will be submitted if we found any further additional information.
Event or Problem Description
It was reported that during pvi transseptal punction, dilator has been made wet with saline solution and put into flushed sheaths.After deaeration trough side port (aspiration with syringe) dilator has been deaerated with slow aspiration of blood and afterwards flushed.During insertion of the transseptal needle no return flow of liquid from dilator was noticed (which is usual for "agilis" which hospital normally use).Deaeration and flushing has been repeated three times but always with same result.Physician decided to switch to "agilis" as he saw a potential higher risk of air embolism.Physician also noticed that he feels that the connector for the syringe of the dilatator is bigger than from other products he used before.As per additional information when the needle is inserted in the dilator, the saline solution is pushed aside and escapes through the proximal end of the dilator, physician did not see this effect and was worried that the dilator might not be air free.The physician commented that it might be due to the patient and maybe not the sheath.There was no patient adverse event reported.No additional information is available.
Additional Manufacturer Narrative
The device was used for treatment.The device was not returned for analysis, therefore, the clinical observation could not be confirmed.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.There is no allegation that the device failed to meet its performance specifications.The end user is noting a preference to using a smaller dilator tipped introducer, not a failure of the device.The dilator tip of the destino reach is larger than that of the agilis device that the customer mentions.Therefore, the rate of flow of liquid would be different due to the difference in diameter.This would just be end user preference.Based on the investigation, a capa is not required.The event will be re-evaluated if additional information becomes available.No further follow-up is required.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 REACH 8.5 STEERABLE GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• MDR Report Key: 8135160
• Report Number: 1035166-2018-00107
• Device Sequence Number: 14034643
• Product Code: DYB
• UDI-Device Identifier: 00885672007225
• UDI-Public: 00885672007225
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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 Model Number: DCR0857717
• Device Catalogue Number: DCR0857717
• Device Lot Number: C8-13093
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1