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

Model Number	0052-3006
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up report will be submitted as soon as the investigation is complete.
Event or Problem Description
On (b)(6) 2021 a (b)(6) female patient underwent a procedure for axillary artery insertion of the impella 5.5.The axillary insertion sheath was bleeding after insertion into the graft despite graft locks in place.Sheath removed and replaced with another without any issue.No patient harm reported.
Additional Manufacturer Narrative
The following sections were updated in followup 1.B4, d9, g3, g6, h2, h3, h6 & h10 one abiomed 23f sheath was returned for analysis.Traces of blood were found inside and outside the sheath.The sheath was observed using a vertex at higher magnification and no cracks, holes or gaps were found.The sheath score lines were observed to be prominent on the outer surface.The sheath was leak tested per iso 11070 standard and procedure for leak test as follows: sheath was occluded at the distal tip using a pin gauge and pressurized to 38kpa and 300kpa.The pressure was held for 30 seconds at 38kpa and 300kpa.The valve was occluded using a seal cap and dilator hub to maintain hemostasis.Further investigation into the extrusion tool showed that the extrusion die change was implemented and excuted.This modification allowed for the score line to break easier during peel and reduce the thickness between score line and outer diameter.This change caused the wall thickness of score line to be lower for easier peel.Review of the drawing showed that lower specification for wall thickness of score line was not specified.The lack of lower specification for wall thickness of score line caused the score line to be prominent.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Upon investigation, there were no cracks or holes observed on the surface of the sheath.The sheath was leak tested as per iso 11070 and no leakage was observed.The sheath was found to be within specification.Investigation of extrusion process revealed that the extrusion die change was implemented to improve the peel strength at the tip.This resulted in thinner score line.Review of drawing showed that there is no lower specification for the score line wall thickness.Procedure for adelante, adelante-s and adelante-s2 sheath extrusion appropriate extrusion tool is selected for the part to be extruded and is inspected prior to the extrusion run.Peel strength and critical dimensions are verified on every 100th extruded sheath as per procedure.Procedure for abiomed introducer sheath in-process and final sample size: 100% inspection the sheath is inspected with a naked eye at a distance of 12" to 18" to ensure the sheath is free of kinks, cracks, splits, sinks and any other damages.Leak test is performed as per procedures.Ifu is provided with the product.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 KIT FOR IMPELLA®
• Common Device Name: 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: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 12674623
• Report Number: 1035166-2021-00122
• Device Sequence Number: 4530716
• Product Code: DYB
• UDI-Device Identifier: 00885672009755
• UDI-Public: 00885672009755
• 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,Followup
• Report Date (Section B): 03/31/2022

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: 07/01/2024
• Device Model Number: 0052-3006
• Device Catalogue Number: 0052-3006
• Device Lot Number: DP-13602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Race: Black Or African American