MAUDE Adverse Event Report: GYRUS ACMI, INC. SINGLE USE ASPIRATION NEEDLE; VIZISHOT 2 FLEX

Model Number NA-U403SX-4019

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to (b)(4) and the sales/product manager noted a preliminary inspection was performed of the device under a microscope.The needle tip and stylet were observed to be intact and the needle could be moved in/out as intended.The needle tip was bent at about the 3cm from the tip which was out of the normal as a nitinol needle generally does not kink.The distal part of the plastic protection sheath was slightly damaged.Additionally, the metal protection tube was missing from the plastic sheath.The sheath was noted in a separate compress.The tube should be tightly attached at the inside of the plastic sheath which prevents the needle from perforating the sheath and the endoscope when the scope is bent.The device will be forwarded to the manufacturer for investigation.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The manufacturer was informed that during a therapeutic endobronchial ultrasound procedure, the end of the kit reportedly had come loose as the needle broke inside the sheath.The doctor reported that the first pass with the needle was normal, the second attempt was somewhat more difficult but without being alerted.When preparing for the 3rd pass, the doctor suddenly felt a higher resistance when trying to push out the needle.The doctor immediately pulled the needle out of the endoscope and saw that something extended from the sheath.The doctor believed it was the needle itself which was broken.The doctor inspected the bronchial of the patient to ensure that nothing broke off the device and fell inside the patient.The procedure was stopped, the patient recovered without any problem, although the anesthesia took more time.

Manufacturer Narrative

This supplemental report was submitted to provide additional information regarding the reported event and to update sections: a3, a4, a5 b6 and h10.The patient did not have any pre-existing conditions.There was no bleeding to the patient observed.The customer is traumatic when the customer tells them about the problem.No portion of the broken needle was left behind.When the needle was inspected it was not observed that the needle was broken.The needle tip could be moved normally in and out of the tip.The needle was not bent.This event occurred in the middle of the procedure.There were no other issues or unusual phenomena during the procedure.The needle did not appear to be buckled when removed.It was unknown what the model number and serial number is of the scope used with the malfunctioning needle.The needle device was inspected prior to use; no anomalies were found.The scope was also inspected prior to use and no anomalies were found.The plastic needle coverage was broken or dislocated.

Manufacturer Narrative

This supplemental report was submitted to provide the results of the investigation performed by the manufacturer.The device history records 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.A total of 475 units were produced under this lot number with no associated ncrs, reported scrap or recorded process deviations relating to the reported failure.The powerbi complaint trending report was reviewed.Review of the complaint trending revealed the current complaint rate falls within acceptable limits, no alerts or alarms have been triggered.No additional complaints tied to this lot number have been reported.Upon evaluation of the returned device, the complaint was confirmed as the laser-cut hypotube (lch) was ejected from the distal end and returned separately packed in a compress.Deformation of the spiral cut needle was observed near the distal end.Additionally, damage to the distal end of the outer sheath was noted.After deploying the needle significant damage to the pebax heat shrink layer was noted.This layer surrounds the spiral cut needle to prevent fluid leakage.The pebax appeared brittle and was cracked along the length of the deployed portion.No additional anomalies were noted, there is no indication that the spiral cut needle itself broke, instead the pebax coating was damaged and the lch was ejected.The lch likely became ejected as a result of the damaged pebax bunching up behind it.The damage and bunching of the pebax layer has been previously observed although a definitive root cause is unknown.Based upon evaluation of devices which have failed in a similar manner, it is known that a significant amount of force is required to push the lch out the distal end of the device.Per the device ifu, "if you feel excessive resistance while operating the needle, do not push the needle slider forcibly.Doing so could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the instrument and/or endoscope." based upon a review of complaint history there is no indication that manufacturing contributed to this failure as no additional reports from other customer accounts have been reported specific to this lot number.Review of complaint trending does not indicate a significant rise in complaint volume related to this or any failure mode associated with this device as neither alert nor action limits have been triggered.No definitive root cause could be identified.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Type of Device: VIZISHOT 2 FLEX
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9963525
• MDR Text Key: 218494724
• Report Number: 2951238-2020-00422
• Device Sequence Number: 1
• Product Code: KTI
• Combination Product (y/n): N
• PMA/PMN Number: K163469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2022
• Device Model Number: NA-U403SX-4019
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 75