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

Model Number 0052-3006

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

Our investigation is still in progress, follow up report will be submitted if we find any further additional information.

Event Description

It was reported that the patient was presented to the physician post-arrest while undergoing cpr.During procedure, 23fr introducer leaked after placement.After attaching to graft, physician noted that the introducer was cracked out of the package.A second 23 fr axillary introducer was opened and used without issue.There was no harm to patient reported.No adverse event was reported.No additional information is available.

Manufacturer Narrative

The device was used in treatment.The device was not returned for analysis.However, evaluation of the device from the different event for the same lot showed reduced wall thickness of the scoreline, which could have made the sheath susceptible to collapsing when used with graft locks, which could have caused leakage.The wall thickness of the scoreline has been reduced to improve the peel strength.However, all devices that have been evaluated have met the current dimensional, visual, and functional requirements in the 23f sheath product specification.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Per abiomed introducer sheath in-process and final inspection :(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 procedure.Ifu - is provided with the product.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing nonconformity.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: INTRODUCER KIT FOR IMPELLA®
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• Manufacturer Contact: doug myers ; 3816 desoto blvd; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 12242380
• MDR Text Key: 264488462
• Report Number: 1035166-2021-00084
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00885672009755
• UDI-Public: 00885672009755
• 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: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Model Number: 0052-3006
• Device Catalogue Number: 0052-3006
• Device Lot Number: PQ0C11882
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2021
• 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 Age: 64 YR
• Patient Sex: Male