MAUDE Adverse Event Report: GYRUS ACMI, INC FLEX-CATCH 4 WIRE NITINOL BASKET; EXTRACTOR, STONE REMOVAL

Model Number NT4F19115

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned.If further information becomes available, a supplemental will be forwarded to the agency.

Event Description

It was reported that the basket broke off in the patient during the procedure.The broken basket was retrieved and removed from the patient.

Manufacturer Narrative

Update to h10: medwatch # 3003790304-2019-00004 is not valid as it was submitted with the wrong mfr number.This should have been submitted under mfr# (b)(4).

Manufacturer Narrative

This supplemental report is being submitted to correct previous h10 statement as no correction to the device lot number is necessary.There is no manufacturer date available and to update h6 with a method code.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results, correct the device lot number and provide the device manufacture date.Please the updates in sections: d10, g4, g7, h2, h3, h6 and h10.The device was returned to the service center in the original product box inside a plastic package.A visual inspection was performed and found the basket completely broken off inside a jar.The remaining parts of the basket were also returned; however, were not placed inside the jar with the basket.The basket was returned in the fully retracted position.As the lever is pushed up/forward as would be done to extend the balloon, the distal end of the device began to bunched up as observed on the pictures.It is unclear what may have caused the basket to fully detach from the device.Since the root cause of the basket breakage could not be determined in this evaluation the investigation results were shared with the original equipment manufacturer (oem).The device was not sent back to the oem for evaluation.The oem, epflex reviewed the investigation for this device and reported the following: the oem states was also unable to determine the exact root cause of the fracture.The oem reported that the minimum tensile strength of baskets is 100% tested and that the breakage is likely due to overloading during medical application.The oem performed a dhr review for this device and there was no deviation or irregularity detected.The oem is taking no additional corrective action as a result of this complaint.

• Brand Name: FLEX-CATCH 4 WIRE NITINOL BASKET
• Type of Device: EXTRACTOR, STONE REMOVAL
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9367085
• MDR Text Key: 204993033
• Report Number: 3003790304-2019-00004
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT-FGO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/27/2020

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 Model Number: NT4F19115
• Device Lot Number: 91807222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/24/2019
• Supplement Dates Manufacturer Received: 11/25/2019; 11/25/2019; 03/27/2020; 03/27/2020
• Supplement Dates FDA Received: 12/06/2019; 12/10/2019; 03/27/2020; 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR