MAUDE Adverse Event Report: OSCOR INC. ADELANTE MAGNUM INTRODUCER SET WITH HEMOSTATIC VALVE; INTRODUCER, CATHETER

Model Number ASM016030

Device Problem Break (1069)

Patient Problems Calcium Deposits/Calcification (1758); Stenosis (2263); No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2019

Event Type  malfunction  

Manufacturer Narrative

Conclusion not yet available - evaluation in progress.This initial mdr is being submitted to meet our requirements of reporting.A follow-up will be submitted as soon as the investigation is complete.

Event Description

The patient was scheduled for a caradic surgery procedure (transcatheter aortic valve replacement), and during the procedure the sheath was broken while exchanging out the sheath.This broke outside the patient's body and did not negatively impact this patient.No adverse patient effects were reported.

Manufacturer Narrative

The following sections were updated in follow-up 1: b4, b7, g4, g7, h2, h3, h6, and h10: the device was used in treatment.One 16f adelante magnum introducer sheath was returned from the customer along with the dilator.There were no other accessories.Traces of blood were found on and inside the sheath and dilator.A 1cm and a 3mm separated fragment of the distal tip of the dilator was also returned in a plastic container.Upon evaluation of the returned product, it was found that the distal tip of the dilator was fractured.Two pieces were returned separated from the dilator tip.The first piece measured approximately 1 cm in length and the second piece measured approximately 3 mm in length.The device history records were reviewed to confirm that the device passed all applicable in process and final inspections.The device analysis revealed no manufacturing defects.The tip of the dilator separated in this case.The distal tips of the dilators are inspected by qa 100% prior to packaging.Potential contributing factors to the detachment of the dilator tip include patient anatomy, and/or the usage of sharp or hard objects (such as guidewires or stents) during the procedure, or excessive force placed on the product during use.The narrowing and calcification mentioned at the femoral access site could potentially contribute to this issue.Multiple attempts were made to gain additional procedural information, but were not successful.Per applicable qa in-process and final inspection procedure: visual inspection: under 10x magnification, verify the tip is round, no flash, no discoloration or other damages.In addition, per applicable qa introducer kit packaging inspection procedure: using a magnification light (2.25x magnification), verify dilator tips are free of any damages.Ensure dilator tip is perfectly round and well opened.This inspection is performed by qa 100%.The instructions for use (ifu) informs the user, caution: do not continue advancement or retraction of the device out of the sheath if resistance is met.Determine the cause of resistance before proceeding.Caution: do not attempt to advance sharp objects/instruments through the hemostatic valve of the sheath.Damage of the valve may result and lead to major blood loss.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 event described in this report.

• Brand Name: ADELANTE MAGNUM INTRODUCER SET WITH HEMOSTATIC VALVE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• MDR Report Key: 8363869
• MDR Text Key: 137426942
• Report Number: 1035166-2019-00013
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00885672004736
• UDI-Public: 00885672004736
• Combination Product (y/n): N
• PMA/PMN Number: K140917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: ASM016030
• Device Catalogue Number: ASM016030
• Device Lot Number: C8-11865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1