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

Model Number	0052-3025
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was used in treatment.One 14f 13cm long abiomed introducer sheath was returned from the customer without the dilator.There were no other accessories.Blood was found on and inside the sheath as well as the sideport tubing.The sheath was returned already peeled/cut apart upon receipt.Upon evaluation of the returned device, it was found that the sheath failed to peel properly along the scoreline.The peel end tip of the sideport portion of the sheath started to look wavy and stopped at approximately 4cm from the distal tip.The sideport portion of the sheath tube was cut down the rest of the length of the tube.The beginning of the peel, directly under the hub looks jagged.Both halves of the inside of the hub were inspected under a microscope at 0.63 power and peeled apart smoothly with no excess material found on either side.The hemostatic valve tore in half normally as well.The break force data of the returned lot was reviewed and it was found that all samples were within manufacturing specification.Possible root cause for peel failure could be tooling wear and tear at the extrusion process.Retraining will be conducted for procedures to prevent recurrence of this issue.The device history record was reviewed to confirm that the device passed all applicable in-process and final inspections.Per procedure for adelante s2s introducer sheath in-process and final inspections, ensures sheaths are inspected for visual, dimensional, and peel functional compliance.Destructive testing sampling plan.Ansi z 1.4, special level iv, and aql 1.0 reduced.Manually break the sheath and hub and verify that the seals split easily without extreme elongation.Also verify that the split cap and seals remain secure and do not break free or loosen from the sheath hub.A) manually peel the sheath and verify the sheath peels easily along the sheath body and tip.Per procedure for adelante, adelante-s and adelante-s2 sheath extrusion the two score line model sheath tubes: perform spc charting on the peel strength and critical dimensions.This is to be performed on every 100th extruded sheath.Measure the peel strength of the extruded sheath per procedure.Measure dimensions a-f using the vertex or optical comparator and the laser micrometer for the ovality.Peel test results and dimensional measurements are to be recorded in the extrusion spc data collection sheet.The spc data collection sheet is to be saved under each work order number in the appropriate folder.Select the extrusion tooling (pin/die) for the part to be extruded.Prior to installing the tooling, measure and inspect the tooling to ensure its suitability for use.Document tooling measurement and condition per procedure.Per ifu flush the sheath with 5 cc of saline immediately before peeling the sheath away in order to minimize backbleeding.First, completely withdraw the sheath from the vessel.Then remove the sheath by sharply snapping the tabs of the valve housing in a plane perpendicular to the long axis of the sheath to split the valve and peel the sheath apart.No further follow-up is required.Based on the investigation, a capa is not required.Qa & manufacturing training was conducted to prevent further occurrence of this event.Oscor will continue to monitor this event type and risk.
Event or Problem Description
It was reported that on (b)(6) 2020 a (b)(6) male underwent a procedure for insertion of an impella cp at the right femoral artery via the 14fr x 13cm introducer.The physician had a difficult time cracking the peel away sheath outside of the body.The physician used a scalpel to carefully cut the peel away sheath.The issue was resolved by placement of the impella and removal of the introducer.The patient was admitted with cancer, flu like symptoms, and a vf arrest.There was no patient harm reported, however, the patient expired when the family chose to withdraw care on (b)(6) 2020.

• Brand Name: INTRODUCER KIT FOR IMPELLA
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 12421682
• Report Number: 1035166-2021-00099
• Device Sequence Number: 4377905
• Product Code: DYB
• UDI-Device Identifier: 00885672009793
• UDI-Public: 00885672009793
• 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
• Report Date (Section B): 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: 0052-3025
• Device Catalogue Number: 0052-3025
• Device Lot Number: C1-17561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR