MAUDE Adverse Event Report: OSCOR INC. INTRODUCER KIT FOR IMPELLA®; INTRODUCER, CATHETER

Model Number	0052-3021
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up report will be submitted as soon as the investigation is complete.
Event or Problem Description
It was reported that the customer was notified of a complaint involving an oscor 23 fr introducer.A (b)(6) male patient underwent a procedure for decompensated post aortic valve replacement and required hemodynamic support from impella rp.The physician reported the introducer splitting while preparing the patient for rp support.A new 23 fr oscor introducer was used without further issue.No patient harm was reported.
Additional Manufacturer Narrative
The device was not returned for analysis, as it was discarded by the customer; however,customer provided the picture of the sheath which showed that sheath was spilt at the distal end.Probable cause of the sheath split could be because the physician utilized the left groin for access, which is not the best practice or sheath met with the resistance while advancing into the patient body.No further follow-up is required.No corrective or preventive action resulted after investigation of this event.The event will be reevaluated if additional information becomes available.Oscor will continue to monitor this event type.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.
Additional Manufacturer Narrative
The device was not returned for analysis, as it was discarded.The investigation was focused on a review of product documentation.Device was used in treatment.The device was not returned for analysis, therefore, the exact cause of the product issue cannot be determined and the clinical observation could not be confirmed.However, following controls are in place to mitigate the reported product issue.The complaint was confirmed using a photo provided by the customer.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Per procedure (abiomed introducer sheath in-process and final inspections): measure dimensions: measure tip i.D.Of sheath using appropriate pin gauges to be in range of 0.305" - 0.307" for 23f.Visual inspection: using 10x magnification, verify the tip is round, no flash protruding greater than 0.4 mm (0.016") and no flash with width (around circumference) greater than 0.7 mm (0.028"), no splitting, cracks or other damages.Per procedure, visual inspection, with naked eye at a distance of 12" to 18", verify the assembled sheath matches the drawing.Ensure parts are free of kinks, cracks, splits, sinks, excessive flash, loose/embedded fm, or any other damages.The instructions for use (ifu) informs the user: never advance or withdraw guidewire or sheath when resistance is met.Determine cause by fluoroscopy and take remedial action.When injecting or aspirating through the sheath, use the sideport only.Avoid subjecting the device to unusual stresses.When assembling the sheath and dilator, care must be taken to insert the dilator tip straight through the center of the valve membrane in order to prevent inadvertent puncturing of the membrane.No further follow-up is required.No corrective or preventive action resulted after investigation of this event.The event will be reevaluated if additional information becomes available.Oscor will continue to monitor this event type.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: INTRODUCER KIT FOR IMPELLA®
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer Contact: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279349835
• MDR Report Key: 14254682
• Report Number: 1035166-2022-00058
• Device Sequence Number: 14702478
• Product Code: DYB
• UDI-Device Identifier: 00885672009786
• UDI-Public: 00885672009786
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 09/16/2022

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 Expiration Date: 07/01/2024
• Device Model Number: 0052-3021
• Device Catalogue Number: 0052-3021
• Device Lot Number: DP-13652
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 09/14/2022; 09/16/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 09/15/2022; 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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
• Patient Age: 73 YR
• Patient Sex: Male