MAUDE Adverse Event Report: OSCOR INC. SAFESHEATH II; INTRODUCER, CATHETER

Model Number	SSL11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/19/2020
Type of Reportable Event	Serious Injury
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
During the lead explant procedure the physician used an amplatz super stiff guidewire to retain access.The guidewire and subsequent introducer 11f sheath perforated through the vessel at the superior vena cava (svc) and the innominate junction.The patient, a (b)(6) male had to have a sternotomy to repair the vessel; patient was hospitalized as a result of the event.No further patient complications have been reported as a result of this event; patient outcome alive with injury.
Event or Problem Description
On 04/07/2021 oscor received additional information from the customer stating there was no direct malfunction of the sheath, the sheath and guidewire perforated the svc vessel and in nominate junction.Customer also stated the product was discarded.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1.Device used in treatment and not returned for analysis.There was no specific malfunction reported by the user.The lot number was not provided by the customer, therefore the device history records could not be reviewed, however, inspection procedures require any oscor product pass all in-process and qa final inspection before shipping to the customer.No further follow-up is required.Based on the investigation, a capa is not required.The event will be re-evaluated if additional information becomes available.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: SAFESHEATH II
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 11274722
• Report Number: 1035166-2021-00012
• Device Sequence Number: 5036063
• Product Code: DYB
• UDI-Device Identifier: 30891492002389
• UDI-Public: 30891492002389
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K122084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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
• Operator of Device: Health Professional
• Device Model Number: SSL11
• Device Catalogue Number: SSL11
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR