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

Model Number	11403001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.The results of the device evaluation will be sent via a follow up medwatch.Reference complaint (b)(4).
Event or Problem Description
As reported: clot reported upon placement of guidewire and sheath.Laser fiber was not inserted yet.Customer pulled out wire and sheath to terminate procedure and pulled out 6 inch of clot.This has happened 3 times in a row (late december, complaints were filed).Dr.(b)(6) said he confirmed there was no clot in the segment prior to gaining access to vein.He did mention one of the patient's tested positive for factor 5.On 1/29, (angiodynamics' reporting representative) went to their next vein clinic day to conference in clinical specialists, dr.(b)(6), and dr.(b)(6).We discovered practice was flushing with the tumescent solution instead of saline.Dr.(b)(6) and dr.(b)(6) shared their professional opinion.Dr.(b)(6) and dr.(b)(6) treated two different patients that the practice and no problems came about.It was reported the disposable device is not available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.Photographs of the thrombosis were provided by the user.The customer's reported complaint description was confirmed via pictures provided.The customer provided a photo which was noted a clot that was removed from the sheath.The clot was observed prior to insertion of the fiber, i.E.No laser energy initiated.In addition, it was reported that the tre-sheath was flushed with tumescent solution instead of normal saline as indicated in the dfu.A definitive root cause for the reported complaint cannot be determined.A review of the device history records via ship history report was performed for the 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 (ic 393) which is supplied to the end user with this catalog number states, "the potential complications include but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, skin pigmentation alteration, neovascularization, paresthesia due to thermal damage of adjacent sensory nerves, anesthetic tumescence, non-target irradiation, hemorrhage, necrosis, dehp exposure, skin burns and pain".Step 10 of the procedure states to "flush the sheath with normal saline".The user manual (man/31/0075), which is supplied to the user with this unit contains the following warnings and statements: "clinical warnings: as with any conventional surgical operations, adverse reactions may occur following treatment", "irradiation of any substance or material other than the target treatment of varicose veins and varicosities may result in a laser burn", "contraindications: the venacure 1470 laser is contraindicated for: · patients with thrombus in the vein segment to be treated · patients with an aneurysmal section in the vein segment to be treated · patients with peripheral artery disease as determined by an ankle-brachial", and, "potential complication: the potential for complications exists, including: · vessel perforation · thrombosis· pulmonary embolism· phlebitis· hematoma· infection· skin pigmentation alteration· neovascularization· paresthesia due to thermal damage of adjacent sensory nerves· anesthetic tumescence· non-target irradiation· hemorrhage· necrosis· dehp exposure· skin burns and pain (this is not an exhaustive list.)".A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference complaint (b)(4).

• Brand Name: VENACURE NEVERTOUCH FIBER
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury, ny
• MDR Report Key: 9700653
• Report Number: 1319211-2020-00012
• Device Sequence Number: 1742607
• Product Code: GEX
• UDI-Device Identifier: H787114030010
• UDI-Public: H787114030010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 11403001
• Device Catalogue Number: H787114030010
• Device Lot Number: 5497234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other