MAUDE Adverse Event Report: OSCOR INC. ABIOMED 14F INTRODUCER KIT FOR IMPELLA; INTRODUCER, CATHETER

Model Number	0052-3000
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was used for treatment.The device was not returned for analysis, therefore, the clinical observation could not be confirmed.The device history record was reviewed to confirm that the device passed all applicable in-process and final inspections.Per procedure abiomed introducer sheath in-process and final inspection 9.2.2 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.Slight discoloration from tipping process is acceptable.Verify proper tip shape according to drawing.Per ifu 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.Dilators, catheters, and pacing leads should be removed slowly from the sheath.Rapid removal may damage the valve membrane resulting in blood flow through the valve.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.Oscor will continue to monitor this event type and risk.
Event or Problem Description
It was reported that during placement of impella cp, sheath broke to 4 pieces in the patient.As per additional information, sheath was torn and there were 4 or 5 longitudinal cracks.Patient loss of 2 liter blood in cath lab, as result 14 units of blood transfusion performed.To prevent the blood loss access site was treated by 25 minute of manual compression and after that vascular surgeon sutured the puncture site.The procedure is aborted and patient was supported by va ecmo.No additional information is available and no other adverse event was reported.

• 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
• MDR Report Key: 8237479
• Report Number: 1035166-2019-00002
• Device Sequence Number: 16196983
• Product Code: DYB
• UDI-Device Identifier: 00813502011562
• UDI-Public: 00813502011562
• 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,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: 0052-3000
• Device Catalogue Number: 0052-3000
• Device Lot Number: C1-15069
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/10/2019
• 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