MAUDE Adverse Event Report: INTEGER/OSCOR INC SAFESHEATH® II; INTRODUCER, CATHETER

Model Number	SSL9
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was used in treatment.There was no performance related failure reported by the user.No further investigation is required.Per the additional information, the physician inadvertently perforated the lead through the patient's heart.The complaint is non-verifiable as the product was not returned as there was no device issue reported.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.
Event or Problem Description
It was reported that during the implant procedure, the physician inadvertently perforated the lead through the patient's heart.The patient's blood pressure dropped significantly after the perforation.Cardiopulmonary resuscitation was performed, and a hospital code blue' was initiated.The patient was sent to the operating room for sternotomy in order to close the perforation.The lead was not implanted.Procedure aborted.No further patient complications have been reported as a result of this event.Product not returning.Medtronic customer reported there is no complaint concerning the oscor product on this event.Non-complaint justification and rationale: there was no allegation against the oscor introducer.The mdt rep stated that the rv lead had perforated the patient's heart tissue.No patient complications have been reported as a result of this event.Not reportable; information/analysis does not indicate a product malfunction.There is no indication of a failure of this marketed device to meet customer or user expectations for quality or to meet performance specifications; thus, the associated line-item tasks will be processed as a non-complaint.(b)(6).(b)(6).

• Brand Name: SAFESHEATH® II
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): INTEGER/OSCOR INC; integer /oscor inc.; 4875 palm harbor bl; palm harbor FL 34683
• Manufacturer (Section G): INTEGER / OSCOR INC; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer Contact: ronnie greco ; 4875 palm harbor blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 23336413
• Report Number: 1035166-2025-00050
• Device Sequence Number: 18506956
• Product Code: DYB
• UDI-Device Identifier: 30891492002358
• UDI-Public: 30891492002358
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/17/2025

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: SSL9
• Device Catalogue Number: SSL9
• Device Lot Number: S9421534
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 84 YR
• Patient Sex: Female