MAUDE Adverse Event Report: ANGIODYNAMICS VENACURE NEVERTOUCH FIBER; VENACURE ENDOVENOUS LASER TREATMENT FIBER

Model Number 11403002

Device Problem Fracture (1260)

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

Event Date 03/24/2022

Event Type  malfunction  

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of tip detached was not confirmed due to the fiber was not returned for evaluation.Without receiving a complaint sample for evaluation a definitive root cause cannot be determined.A potential root cause for this type of failure mode (gold tip detached within tre-sheath) is when retracting fiber into tre-sheath after first ablation and dried blood at gold tip can inhibit smooth withdrawal.At this point if end user applies excess force to remove/pull back fiber then the gold tip can detach.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: the instructions for use which is supplied to the end user with this catalog number contains the following statement "prior to and during use, avoid damaging the fiber by striking, stressing, or excessive bending.Do not coil the fiber tighter than a diameter of 20cm" and "pull the sheath back and lock it to the sheath-lok fitting." a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

Event Description

A nurse reported an issue with a nevertouch 65cm kit.During a procedure, the tip of the laser fiber detached and remained inside the guidance catheter [tre-sheath].The devices were removed and a new of the same device was used to complete the procedure.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.

• Brand Name: VENACURE NEVERTOUCH FIBER
• Type of Device: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 14135572
• MDR Text Key: 289538218
• Report Number: 1319211-2022-00017
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: H787114030020
• UDI-Public: H787114030020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2022

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 Expiration Date: 01/31/2024
• Device Model Number: 11403002
• Device Catalogue Number: 11403002
• Device Lot Number: 5661822
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male