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

Model Number NT4F19115

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

The referenced device was not returned for evaluation; therefore, the cause of the reported event cannot be determined.A review of the device history records (dhr) was performed for the concerned lot number which indicated that the production has been done according to the valid specifications.All process steps and all inspections have been done as prescribed.If the device is returned at a later date, this report will be supplemented accordingly.

Event Description

The manufacturer was informed that during the middle of a cystoscopy/ureteroscopy with stent placement and laser lithotripsy, the doctor deployed the basket to retrieve the stone and the basket of the device got stuck.While moving the basket, the tip fell off inside the patient.The broken basket was retrieved from the patient using a pair of flexible graspers with no issues.The procedure was delayed by five minutes and was completed with a new basket.There was no patient injury reported and the patient was in stable condition.Additionally, the device was inspected and no anomalies were detected.The physician is experienced with this device and was trained by a their local sales representative.

Manufacturer Narrative

The referenced device was returned to the service center for evaluation.The device was received with a zip tie around the lever, appearing to hold it from retracting.It was confirmed that the distal end of the basket was missing, as there was no basket remaining on the returned device.With the device fully extended, approximately 3mm of the hypotube remained at the distal end.The exact cause of the reported event could not be conclusively determined.

Manufacturer Narrative

Based on the provided pictures and the results of the physical evaluation, the oem (epflex) concluded the fact that the basket portion was broken from the pull wire, the most probable cause of the reported event was attributed to excessive overload, as the strength was tested 100% by epflex.The breakage cannot be reconstructed.

Manufacturer Narrative

The clinical leader at the user facility further reported the following: the reported event occurred in during the middle of a cystoscopy with ureteroscopy, stent placement, laser lithotripsy procedure.The procedure was completed with a new basket.There may have been a slight delay of 5 minutes.The doctor had deployed the basket to retrieve the stone and the tip broke right off.The basket was removed through the flexible ureteroscope and the broken tip was removed with a pair of flexible graspers.The procedure also used an olympus flexible ureteroscope.There was no patient injury reported and the patient was stable.Additionally, prior to procedure the device was inspected and no anomalies were detected.It was unknown if an x-ray image was taken when the device was stuck inside the patient.The physician was experienced with the referenced device and was trained by their local sales representative.

• 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: 9526059
• MDR Text Key: 204566125
• Report Number: 2951238-2019-01236
• 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
• Report Date: 02/10/2020

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: Health Professional
• Device Model Number: NT4F19115
• Device Lot Number: 91807225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/23/2019; 02/04/2020; 02/10/2020
• Supplement Dates FDA Received: 01/02/2020; 02/04/2020; 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 77