MAUDE Adverse Event Report: OSCOR INC. ADELANTE® PEEL-AWAY INTRODUCER SET; INTRODUCER, CATHETER

Model Number AP06016B5

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/08/2023

Event Type  Injury  

Manufacturer Narrative

The device was used in treatment.A needle, guidewire, sheath and dilator from an adelante 6f introducer sheath kit were returned from the customer for analysis.Blood was found on the needle and guidewire only.Returned device analysis revealed the needle and guidewire were within manufacturing specifications.Upon receipt of the product, the guidewire could not be removed from the needle.After thorough cleaning and decontamination, the guidewire still could not be removed from the needle.As per the instructions for use (ifu): do not withdraw the guidewire back into the cannula as this may result in separation of the guidewire.The cannula should be removed first.Also, the guidewire should not be advanced when resistance is felt.It is unknown if the end user followed the ifu guidelines.The dimensions of both needle and guidewire were within manufacturing specifications.There were no manufacturing defects recorded in the device history records.The root cause cannot be determined.No manufacturing defects were found.The 0.038" guidewires are inspected at the supplier's site and are provided with a certificate of conformance (coc) demonstrating the product met specifications as required from the supplier.According to oscor's inspection sheet, the following inspections are performed at an aql level of 0.25: using a 10x microscope, tips and proximal ends are verified if they are convex and flexible.Body of the guidewire is verified to be stiff.Also, it is ensured that the weld at the guidewire tip has no damage or incomplete weld.The guidewire is rubbed with fingers to check for smooth surface.The needles are inspected at the supplier's site and are provided with a certificate of conformance (coc) demonstrating the product met specifications as required from the supplier.According to oscor's inspection sheet the following inspections are performed at an aql level of 0.15: needle opening must be lined up with arrow, visually at 18".Measure dim c: measure id of protective sheath using pin gauges.The instructions for use (ifu) informs the user: using standard percutaneous technique, insert the needle into the desired area, and verify position under fluoroscopy and by observing fluid return.Holding the needle firmly in place, insert a guidewire through the needle cannula and into the desired area.Use the j-tip straightener for a j-tip guidewire.Warning: the blue straightener must be placed into the needle hub from the outside only; never put it directly into the vein! gently advance the guidewire to the desired depth.Holding the guidewire in place, withdraw the needle cannula.Minimize blood loss by applying pressure over the puncture site.Caution: when using a metal needle cannula, do not withdraw the guidewire into the cannula.Shearing of the guidewire may result; remove the cannula first.Caution: do not advance the guidewire or introducer assembly under resistance.Determine the cause of resistance through fluoroscopic examination.No follow-up required.No corrective or preventive action resulted after investigation of this event.Risk remains acceptable and no new failure mode identified.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.

Event Description

During difficult punction procedure from the v axillaris, the seldinger wire (german name for guidewire) wouldn't pass through the 18-gauge needle.Event took place intraoperatively, during first implantation; the wire can't move backwards again, and completely blocked the lumen.Changed to another competitor's introducer, the procedure was completed successfully.No patient adverse effect reported.The icd / ipg remains active, no change.Additional information received on 29/aug/2023, there was a procedure delay for approximately 30 minutes.Submission for administrative purposes.

• Brand Name: ADELANTE® PEEL-AWAY INTRODUCER SET
• 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: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 17799799
• MDR Text Key: 324052571
• Report Number: 1035166-2023-00106
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K073100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AP06016B5
• Device Catalogue Number: AP06016B5
• Device Lot Number: DP-17993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2023
• 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 Outcome(s): Hospitalization