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

Model Number 0052-3021

Device Problems Break (1069); Crack (1135); Deformation Due to Compressive Stress (2889)

Patient Problems Death (1802); Myocardial Infarction (1969); Shock (2072)

Event Date 05/12/2018

Event Type  Death  

Manufacturer Narrative

During our investigation it was discovered, the initial mdr 1035166-2018-00064 report had failed submission.Based upon our findings, we have resubmitted this initial mdr report.Concomitant medical products: impella rp 004343, serial number: (b)(4), lot number 1314688.Date: (b)(6) 2018.Conclusion not yet available as the investigation is on-going.

Event Description

The patient was presented with ami (acute myocardial infarction) with shock, impella post pci (percutaneous coronary intervention).After second attempt at impella rp insertion via 23fr sheath, distal tip of introducer sheath was misshaped (wavy) and crack/break was noted on introducer hub.When md was able to remove impella rp, new impella rp pitched and inserted into patient.There were no reported issues noted with the product prior to the procedure.The patient was not obese, no excessive force was used to deliver this introducer.The rep also reported that there was significant bleeding at the reported crack/ break; more than 2 units of replacement blood products were given to the patient.The family withdrew support and the patient subsequently expired.

Manufacturer Narrative

Device used in treatment.For bleeding more than 2 units of replacement blood products were given to the patient.The family withdrew support and the patient subsequently expired.One 23 fr abiomed introducer sheath was received from the customer without the dilator.No other accessories were received with this device.Blood was found on and inside the sheath.The distal tip circumference edge was damaged.The hemostasis valve was heavily damaged.Upon evaluation of the returned product, it was found that there was impact damage (waviness) around the circumference of the distal tip edge as stated in the event description.The hemostasis valve was heavily damaged/torn in a few places.The introducer was then tested using the iso liquid leakage test.The device was connected at the distal tip and pressurized to less than 1.5kpa before the sheath started leaking at the crack in the hub and at the damaged hemostasis valve.The crack in the hub was confirmed when viewed under a 10x microscope and when leak tested.The customer complaint also indicated that there were several kinks in the sheath.No kinks in the sheath were found.Returned device analysis reveals one 23f abiomed introducer sheath that is within manufacturing specifications.No manufacturing defects were found.Potential contributing factors to the damages of the sheath 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).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 will continue to monitor this event type and risk.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.The leak test is performed by qa on 100% of the sheaths.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.Avoid subjecting the device to unusual stresses.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.

• Brand Name: INTRODUCER KIT FOR IMPELLA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 de soto blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC.; 3816 de soto blvd.; palm harbor FL 34683
• Manufacturer Contact: doug myers ; 3816 de soto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 7920303
• MDR Text Key: 122130710
• Report Number: 1035166-2018-00064
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00813502011517
• UDI-Public: 00813502011517
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: 0052-3021
• Device Catalogue Number: 0052-3021
• Device Lot Number: C1-13849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2017
• 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): Death
• Patient Age: 65 YR