MAUDE Adverse Event Report: SURGE CARDIOVASCULAR SURGE CARDIOVASCULAR; RIGID INTRACARDIAC SUCKER

Model Number 4300S

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

On august 11, 2016, the manufacturer was notified of a sucker tip falling off into a patient's heart chamber.The part number associated with this filing is 4300s (intracardiac sucker - private label).The lot number associated with this filing is 63066-011116.In the incident report, it was indicated that the observed malfunction did not delay the procedure or cause or contribute to any adverse patient or user effect and the procedure was completed successfully.A sample was returned to the manufacturer and the tip was clearly removed from the tube, confirming the report.In the initial investigation of the product's dhr, no abnormalities were found in the incoming inspections of raw materials nor in the manufacturing process of the device.After the dhr review and parallel review of the sample, the contract manufacturer suggested that the potential root cause could be insufficient adhesive present at the bond joint.Prior to receiving this report, the manufacturer was adding continuous improvement to the manufacturing process to include a 100% in-line pull test of the tip as part of the manufacturing bend fixture.This 100% go/nogo inspection step is performed after bonding the tip to the tube.The fixture performs an in-line pull test on the tip to determine if the bond is sufficient.If the adhesive is not present, the fixture will not allow continuation to the next step of the assembly process (bending of the tube); therefore, providing a clear, visual and lock-out indicator to the operator that the bond joint is not sufficient.The validations of inspection fixture have since been completed and accepted.While the automatic fixture pull test was being built and validated, the manufacturer had implemented a 100% manual operator pull and twist test in april 2016.The operator performs a manual pull and twist test once the bonding step is complete.If the tip moves at all, the operator rejects based on the knowledge that the bond was not sufficient.As part of continuous improvement, the inner diameter of the sucker tip was evaluated for change to assess area for adhesive and bond strength.The enlarging of the id would provide the operator a second indicator of adhesive presence as the tip was shown to exhibit equivalent or higher pull strength with adhesive.The manufacturer has created samples of the enlarged id for pull testing.Automatic fixturing for 100% confirmation of strength and glue are in place and provide an excellent solution for reducing the process risk of insufficient glue.The change to a larger id tip is still under evaluation as a continuous improvement effort; it will be implemented if added improvement without risk is identified.Surge takes the issues related to patient contact very seriously and strives to always improve and refine current inspection methods and process methods.Note: on march 24, 2017, complaint files were reviewed by a contract ra/qa consulting group where this occurence was identified to be in-line with the scope of a malfunction per 21 cfr 803.Based on this review, the mdr was filed.

Event Description

Plastic sucker tip came off metal shaft.Plastic tip fell into patient's heart chamber.

• Brand Name: SURGE CARDIOVASCULAR
• Type of Device: RIGID INTRACARDIAC SUCKER
• Manufacturer (Section D): SURGE CARDIOVASCULAR; 2680 walker avenue nw, suite c; walker MI 49544
• Manufacturer (Section G): SURGE CARDIOVASCULAR; 2680 walker avenue nw, suite c; walker MI 49544
• Manufacturer Contact: clara illing ; 2680 walker avenue nw, suite c; walker, MI 49544 ; 2696290300
• MDR Report Key: 6450426
• MDR Text Key: 71621784
• Report Number: 3004986960-2017-00001
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• PMA/PMN Number: K971022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 03/30/2017

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
• Device Operator: No Information
• Device Expiration Date: 12/11/2019
• Device Model Number: 4300S
• Device Catalogue Number: 4300S
• Device Lot Number: 63066-011116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1