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

Model Number D141101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

Our investigation is still in progress, follow up report will be submitted if we find any further additional information.

Event Description

It was reported that, after placing guidestar steerable sheath into the left atrium the transient st elevation happened.Medication required to treat st elevation.Cause of the st elevation is unknown.No other patient side effects reported.No additional information is available.

Manufacturer Narrative

The following sections were updated in follow-up.The device was used in treatment and not returned for analysis.There was no specific performance related failure reported by the user.According to the user, transseptal puncture and sheath positioning into the la might determine coronary spasm and transient st elevation.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.No further investigation is required based on the investigation, a capa is not 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: GUIDESTAR STEERABLE GUIDING SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• MDR Report Key: 10819552
• MDR Text Key: 215619496
• Report Number: 1035166-2020-00073
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00885672009496
• UDI-Public: 00885672009496
• Combination Product (y/n): N
• PMA/PMN Number: K140406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: D141101
• Device Catalogue Number: D141101
• Device Lot Number: OR-04983
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention