MAUDE Adverse Event Report: OSCOR INC. ABIOMED INTRODUCER 23F S30CM D37CM TKIT; INTRODUCER, CATHETER

Model Number 0052-3021

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problems Hemostasis (1895); Blood Loss (2597)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

Our investigation is still in progress ,follow up report will be submitted if we found any further additional information.

Event Description

It was reported that during cardiomyopathy sheath was leaking.Physician attributed this issue due to a potential crack in the introducer.After unscrewing and taking dilator out carefully, physician attempted to place impella rp through it and it started bleeding and impella rp not able to advance into left pulmonary artery.User removed the impella and sheath was exchanged, impella insertion went smoothly.It was reported that approximately 100 cc blood was lost and cardiothoracic surgeon physician's assistant purse string suture with good hemostasis.Patient received successful support, thereafter.No additional information is available and no other adverse event reported.

Manufacturer Narrative

The device was in use for treatment.One 23f abiomed introducer sheath was returned from the customer with the dilator.There were no other accessories.Visible blood was found on and inside the sheath and dilator.The introducer sheath was leak tested with water and a syringe connected to the sideport.Water leaked from one side of the hub.Upon evaluation under a microscope, a crack was found in the hub break-line on side b.The entire length of crack which is approximately 8 mm in length, with a larger/wider of the portion covering approximately 3 mm.The hemostatic valve had a small tear in it but water did not exhibit leakage when tested.The distal tip of the sheath was damaged around the circumference of the tip.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Returned device analysis revealed the 23f abiomed introducer sheath was within manufacturing specifications.No manufacturing defects were found.Potential contributing factors to the damages of the sheath (resulting in leakage) is if the device was advanced through an area of resistance (as stated in the precautions of the ifu), or if the device was subjected to unusual stresses (as stated in the handling and storage section of the ifu).As per procedure abiomed introducer sheath in-process and final inspection, the devices in this lot were inspected as follows: 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.Per section 12.2, 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.Perform leak test per procedure.The leak test is performed by qa on 100% of the sheaths.Per ifu 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.Aspiration and saline flushing of the sheath, dilator, and valve should be performed to help minimize the potential for air embolism and clot formation.Infusion through the sideport can be done only after all air is removed from the unit.Indwelling introducer sheaths should be internally supported by a catheter, lead, or dilator.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.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.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.Event assessment form initiated to include a new failure mode for risk file.The risk is currently estimated at low for this type of incident.The event will be re-evaluated 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: ABIOMED INTRODUCER 23F S30CM D37CM TKIT
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm habror FL 34683
• MDR Report Key: 8463777
• MDR Text Key: 140284057
• Report Number: 1035166-2019-00029
• 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: 05/22/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: 0052-3021
• Device Catalogue Number: 0052-3021
• Device Lot Number: C1-14257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 04/29/2019
• Supplement Dates FDA Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention