MAUDE Adverse Event Report: GYRUS ACMI, INC X-CATCH NT (2.2 FR X 115 CM) STONE RETRIEVAL DEVICE

Model Number NTCP22115

Device Problem Break (1069)

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

Event Date 06/08/2021

Event Type  malfunction  

Event Description

As reported, the basket was broken when it was inserted inside the patient.According to the reporter, this is the second case, they did not keep the first broken basket.There are no further details provided regarding the event reported.There is no patient harm or injury reported due to the event.No user injury reported.Device return evaluation found the basket broke near the middle, instead of at the distal tip or the sheath end of the basket, describing the basket breaking in a certain way (fish hook) formation was observed.

Manufacturer Narrative

The subject device was received and evaluated.The device returned in its original packaging.Using the label on the packaging, the model and lot number were confirmed.The device returned with the basket in the fully deployed position.The introducer is engaged onto the nose cap as intended.The nose cap is engaged on the nose cone as intended.The distal end of the sheath had some signs of gross use from some combination of tissue or blood.The sheath length was measured to be 1140 mm which is included in the working length.The sheath is in good condition, without any visible kinks, blemishes, or buckling.The sheath is still connected near the handle.The introducer was removed and the heath shrink was examined to be in good condition without damage or being bent.As stated during visual inspection, the basket is deployed, however, the basket has visibly broken wires approximately 0.793 cm from the distal end of the sheath in multiple locations.All parts of the basket are accounted for and there are no missing pieces.The hypotube has been push into the sheath.When retracting the basket, there was significant resistance when both retracting and deploying the basket.This is likely caused by the movement of the hypotube and the damaged basket.The initial complaint of basket damage can likely be confirmed.The basket broke near the middle, instead of at the distal tip or the sheath end of the basket, the "fish hook" formation is observed.The dhrs (device history record s) for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Review on this lot number found no associated ncrs (non conformance), reported scrap or recorded process deviations relating to the reported failure.The observed failure is a known phenomenon likely resulting from possible contact with a laser during procedure.The device ifu (instruction for use), it states : do not directly fire any lithotripsy system (pneumatic, ultrasonic, laser or other) upon the device as significant damage and patient injury may occur.Olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response and updates.The following sections were updated: b5 ,g3, g6, h2, h6 and h10.

Event Description

Updates from customer response on event/problem reported : the basket would not open.Another basket was used and the intended procedure was completed.No further information was provided.

• Brand Name: X-CATCH NT (2.2 FR X 115 CM) STONE RETRIEVAL DEVICE
• Type of Device: X-CATCH NT (2.2 FR X 115 CM) STONE RETRIEVAL DEVICE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12450250
• MDR Text Key: 283627156
• Report Number: 3011050570-2021-00103
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 00821925027695
• UDI-Public: 00821925027695
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NTCP22115
• Device Lot Number: KR107481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1