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

Model Number	0052-3006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 a (b)(6) male admitted suffering from cardiomyopathy underwent a procedure for access at axillary graft for placement of the impella 5.5.Today a complaint was filed inclusive of your introducer packaged within our axillary set.The field rep noted the sheath cracked during placement into the graft and placing graft locks.Patient reported as stable.It is unknown if there was a delay in the procedure.No medical intervention was given.Patient is still on impella support.The procedure was completed with a new sheath.
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
Additional information received 06/03/2022.Sheath crack was confirmed by physician before placement.Sheath cracked on distal tip of sheath along striations.Leaking not confirmed as physician did not want to use this sheath in this procedure, new sheath requested.
Additional Manufacturer Narrative
One abiomed axillary 23f sheath was received.There were no other accessories.Traces of blood were found on the sheath.According to the event description summary sheath cracked during placement into the graft and placing graft locks.Upon evaluation with naked eye a 3-4mm crack was found on the score line of the sheath shaft.The lot number was not provided by the customer; therefore, the device history record could not be reviewed, however, inspection procedures require any oscor product to pass all in-process and qa final inspection before shipping to the customer.Returned device analysis revealed the sheath was within manufacturing specification.A 3-4mm crack was found on the score line of the sheath shaft.Although the exact cause is unknown, it is possible that resistance was encountered while in use causing the sheath to crack.The sheaths are inspected by qa for cracks and damage and are also leak tested in-process 100%.Since the lot number is unknown, the dhr cannot be reviewed to see if there's any related issues or anomalies.Per procedure (adelante s2s introducer sheath in-process and final inspections) sample size: 100% with naked eye at a distance of 12" to 18", qa personnel must to verify that the assembled sheath matches the drawing.Ensure parts are free of kinks, cracks, splits, sinks, excessive flash, loose/embedded fm.The instructions for use (ifu) informs the user: 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.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.

• Brand Name: ABIOMED INTRODUCER KIT FOR IMPELLA®
• Common Device Name: INTRODUCER, CATHETER, PRODUCT CODE: DYB
• 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 ; 7279352511
• MDR Report Key: 14592051
• Report Number: 1035166-2022-00069
• Device Sequence Number: 12151427
• 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): 11/10/2022

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 Model Number: 0052-3006
• Device Catalogue Number: 0052-3006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 60 YR
• Patient Sex: Male