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

Model Number 0052-3021

Device Problem Peeled/Delaminated (1454)

Patient Problems Perforation of Vessels (2135); Heart Failure/Congestive Heart Failure (4446)

Event Date 02/24/2022

Event Type  Injury  

Event Description

It was reported that during a procedure for an acute myocardial infarction/cardiogenic shock after insertion of the 23 fr oscor introducer, an opaque structure was seen under imagery.When the introducer was advanced, the structure moved with the device.The procedure was halted and an angiography was taken, revealing a peel in the lock of the introducer - one portion was found perforating the left femoral vein.The patient a (b)(6) female was then transferred for escalation of care, with the introducer still in the patient's body.Once patient was transferred, vascular surgery was performed.The patient expired after therapy was discontinued.

Manufacturer Narrative

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

Event Description

Corrected event description submitted to bfarm from the physician: the following problem occurred during the implantation of the sheath required for the impella rp: after a simple puncture of the right femoral vein, first a guide wire and then a 6f sheath was inserted, over which the implantation wire of the impella rp sheath was inserted.Sequential dilatation of the vessel via this wire.Visual and haptic inspection of the 23f sheath.Then insertion of the 23f impella rp sheath.This was done with moderate pressure under fluoroscopic control and wire guided.Then a semi radiopaque structure is noticed.The company support, who was present during the implantation, could not comment on this.When trying to insert the sheath further, this structure moves with it.The procedure is stopped immediately and an angiography is performed.The angiography shows that the tip of the sheath is peeled and that one part of the sheath is in the vein and the other part is in the tissue after presumed perforation of the vein wall.The procedure is discontinued and the sheath is left in situ.Presentation of the patient at the cardiac center and transfer for further therapy.The patient suffers from bilateral pump failure and should be supported biventricularly for this reason.Biventricular support.Prior to this, an impella cp left ventricular assist pump.With this pump the patient could be stabilized for transport." information received on (b)(6) 2022: patient was already in very poor condition on arrival at the hospital ((b)(6) 2022).Patient had bilateral pump failure.Patient probably would have died even with successful surgery with no incident.Patient was very unstable on the operating table before surgery started.It is very likely that the patient did not die because of the misplaced/split introducer.It seems unlikely that the impella rp would have really helped the patient in the long term.Diagnosis when patient arrived in hospital was so severe that this would have led to complete heart failure in the long term.One year ago patient had a good ventricular function and good ejection of the heart.On admission to the hospital, the patient had an ejection fraction of 10-15%.This indicates severe heart failure.Additional information received on (b)(6) 2022: it was reported that the patient was unstable when presented to the physician.The patient was transferred to a second hospital with the introducer left in place and once received she underwent vascular surgery.On (b)(6) 2022, the patient expired after therapy was discontinued.

Manufacturer Narrative

One 23f abiomed introducer sheath was returned from the customer without the dilator.Two blue non-vented luer lock caps were attached to the stopcock.There were no other accessories.Blood was found on and inside the sheath.Upon evaluation of the returned product, it was found that the sheath had two splits in the shaft along the scorelines.One split measured approximately 11cm from the distal tip and the other split measured approximately 7.5cm from the distal tip.Both splits were found along the scoreline of the sheath shaft.The distal tip of the sheath was slightly damaged/irregular in shape around the edge most likely due to the splits in the sheath.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Returned device analysis revealed the sheath was split in two places along the scorelines.One split was located approximately 11cm from the distal tip and the other was approximately 7.5cm from the distal tip.There was also slight damage on the distal tip.The sheaths are inspected by qa for cracks and damage and are also leak tested in-process 100% per procedure.The break force data was reviewed and there were no rejects noted on the record.No manufacturing rejects or anomalies of this type were recorded in the dhr.The introducer sheath passed all in-process and qa final inspections before shipping to the customer, including visual, dimensional and leak testing.The root cause of the split occurrence could not be determined.No manufacturing defects were found.Per procedure (adelante s2s introducer sheath in-process and final inspection) final assembly inspect 100% for steps 12.2 and 12.3 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.Foreign matter (fm)/fiber is limited to 2 particles < 0.10 mm2 or 1 particle < 0.2 mm2 with naked eye at a distance of 12" to 18", verify the sheath hub and split caps are free of excess silicone oil applied between the seals during assembly.Verify split caps are properly placed and secured onto sheath hub and free of cracks/damages or excessive adhesive.Vacuum leak test perform pressure and vacuum leak test per procedure.The ifu was provided to the customer as part of the product.No further follow-up is required.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.In addition, there was no new failure mode identified and the risk remains acceptable.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.

• 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 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer Contact: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 13846572
• MDR Text Key: 287603369
• Report Number: 1035166-2022-00039
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00813502010558
• UDI-Public: 00813502010558
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0052-3021
• Device Catalogue Number: 0052-3021
• Device Lot Number: DP-13404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Death; Life Threatening
• Patient Age: 63 YR
• Patient Sex: Female