MAUDE Adverse Event Report: OSCOR INC ABIOMED 14F 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	Perforation of Vessels (2135)
Date of Event	03/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: a preliminary review showed there were no manufacturing rejects or anomalies of this event type recorded in the device history record.Conclusion not yet available as the investigation is on-going.H11: during our final investigation, it was discovered the initial mdr 1035166-2018-00036 (b)(4) report had failed submission.Based upon our findings, we have corrected the reported failure in this initial mdr report.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
On (b)(6) 2018, during a hrpci procedure, the dilator perforated a l-iliac artery.The physician observed the incident during the actual procedure.After the physician had used the abiomed.018 wire and the benson wire, it was noted that the dilator perforated l- iliac.A balloon used to control bleeding and the perforation was repaired.A 7f introducer was used above perforation to do intervention and the impella was placed without issue inside r-iliac.The physician used balloon and stents to rca and kissing balloons and stents to lad, lm and circ.Preclose x 2 was also utilized.Patient was reported to be stable.
Additional Manufacturer Narrative
This report is being submitted retrospectively per fda request during our final investigation, it was discovered the initial mdr cmp (b)(4) report had failed submission.Based upon our findings, we have corrected the reported failure in tmdr follow up 2 mdr submitted on 09/26/2018.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
On (b)(6) 2018, during a hrpci procedure, the dilator perforated a l-iliac artery.The physician observed the incident during the actual procedure.After the physician had used the abiomed.018 wire and the benson wire, it was noted that the dilator perforated l- iliac.A balloon used to control bleeding and the perforation was repaired.A 7f introducer was used above perforation to do intervention and the impella was placed without issue inside r-iliac.The physician used balloon and stents to rca and kissing balloons and stents to lad, lm and circ.Preclose x 2 was also utilized.Patient was reported to be stable.

• Brand Name: ABIOMED 14F 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: doug myers ; 3816 desoto blvd; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 7902918
• Report Number: 1035166-2018-00036
• Device Sequence Number: 12494766
• 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
• 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): 09/24/2018

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: 12/01/2020
• Device Model Number: 0052-3025
• Device Catalogue Number: 0052-3025
• Device Lot Number: C1-13895
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 03/28/2018; 03/28/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 09/24/2018; 09/24/2018
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• 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: Required Intervention
• Patient Sex: Unknown