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

Model Number	0052-3025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.
Event or Problem Description
We have been notified of a complaint involving an oscor 14fr x 13cm introducer (material #0052-3025, lot # c1-16469).The physician accessed the patient's right common femoral artery without issue and proceeded to dilate the insertion site with a 8fr, 10fr, 12fr dilators, respectively.The introducer was placed without any reported issues, however, the physician noticed a perforation in the artery.Nothing stood out on introducer sheath that indicated there was any damage with the introducer that caused or contributed to this event.The procedure was aborted and successfully completed the next day with a new introducer (14fr x 13 cm oscor) and new impella.No intervention/surgical repair due to not being able to access contralaterally because of previous hip replacement wound healing.The perforation was just proximal to the insertion sight, manual compression applied until hemostasis was achieved.There was no adverse impact to patient.Additional information has been requested.
Additional Manufacturer Narrative
The device was used for treatment.There was no product performance issue reported.The device was not returned for evaluation, therefore, the clinical observation could not be confirmed.The device history records were reviewed to confirm that the device passed all applicable in process and final inspections before shipping to the customer.Based on the investigation, a capa is not required as there was no issue reported for the device performance or quality.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.
Event or Problem Description
As per additional information, there was no damage to introducer reported.The interventional cardiologist discovered the perforation prior to inserting the cp into the 14 fr sheath.Patient was stable from the previous day, due to the urgent necessity of treating the patient the decision was made to attempt the ppci again the following day.Introducer is not available as it was discarded by the customer.

• Brand Name: ABIOMED INTRODUCER KIT FOR IMPELLA
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• MDR Report Key: 9349071
• Report Number: 1035166-2019-00104
• Device Sequence Number: 19372545
• Product Code: DYB
• UDI-Device Identifier: 00813502010664
• UDI-Public: 00813502010664
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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 Expiration Date: 04/01/2022
• Device Model Number: 0052-3025
• Device Catalogue Number: 0052-3025
• Device Lot Number: C1-16469
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 02/13/2020
• 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: 64 YR