MAUDE Adverse Event Report: OSCOR INC. ABIOMED 23F INTRODUCER KIT FOR IMPELLA; INTRODUCER, CATHETER

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

Patient Problems Death (1802); No Code Available (3191)

Event Date 06/17/2019

Event Type  Injury  

Manufacturer Narrative

Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.

Event Description

On (b)(6) 2019, the patient a (b)(6) year old, hispanic, female was presented to physician in shock post cabg (coronary artery bypass grafting).During placement of impella cp via the femoral artery the physician placed the 23fr in error to the femoral artery, rather than the 14fr introducer.Patient's abdomen was rigid in the cath lab, decision was made to stabilize patient first then address the abdomen.The vascular surgeon came and the vessel was repaired by placing 3 self-expanding stents to the iliac.Investigation is still in progress; additional information has been requested.

Manufacturer Narrative

The following sections were updated in follow-up 1: b4, b5, g4, g7, h2, h6, and h10: the device was used in treatment.The device was not returned for evaulation.There was no specific performance related failure reported by the user.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 oscor product to pass all in-process and qa final inspections before shipping to the customer.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 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 Description

The representative reported the patient expired on (b)(6)2019 , they think the family withdrew care.The representative does not have the pump or introducers to return to corporate.As far as the cause of death, the representative does not know what the official cause of death was determined to be.There were multiple physicians on the case and they are not sure which physician made the final decision on the cause of death.

• Brand Name: ABIOMED 23F INTRODUCER KIT FOR IMPELLA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• MDR Report Key: 8805193
• MDR Text Key: 151559531
• Report Number: 1035166-2019-00059
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K122084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR