MAUDE Adverse Event Report: OSCOR INC ARRIVE¿ BRAIDED TRANSSEPTAL SHEATH; INTRODUCER, CATHETER

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

Patient Problem Bradycardia (1751)

Event Date 07/05/2019

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 during cryo ablation procedure, physician successfully performed the ablation of the four pulmonary veins.At the end of the procedure when he was checking the results of the procedure, he find out that patient had bradycardia.Patient has been paced and had cardiac massage, pericar diocentesis and pharmacological treatments for 2 hours but he died.Patient died on (b)(6) ,2019.However, no alleged product issue reported.

Event Description

As per additional information, patient was presented to physician in good condition.As per physician, patient might had coronaropathy "by stander".The death was caused by electromechanical dissociation.

Manufacturer Narrative

Device used in treatment.The device will not returned for evaluation.The lot number of this device was not provided, therefore neither a review of the device history record nor complaint history could be performed.Inspection procedures require any oscor product pass all in-process and qa final inspections before shipping to the customer.There was no performance related failure reported by the user.No further investigation is required.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.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: ARRIVE¿ BRAIDED TRANSSEPTAL SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd; palm harbor FL 34683 1816
• MDR Report Key: 8880253
• MDR Text Key: 153873907
• Report Number: 1035166-2019-00068
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K101497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/09/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 77