MAUDE Adverse Event Report: ANGIODYNAMICS, INC MICRO-INTRODUCER KITS

Catalog Number H787065970535

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/19/2019

Event Type  Injury  

Manufacturer Narrative

The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint # (b)(4).

Event Description

On (b)(6) 2019, a patient came in for a neuro intervention.While attempting to get vascular access in the right groin, a part of the wire broke off in the body.The md then went over to the left groin, obtained access and continued with the neuro procedure.Once the case was completed, a vascular surgeon scrubbed in, obtained additional imaging of the wire in the groin and was able to remove the wire shortly after.The reported defective disposable device has been returned to the manufacturer for evaluation.

Manufacturer Narrative

Returned for assessment was a venacure1470 laser (sn (b)(4)).Functional testing was performed on the returned unit.The unit passed all testing and met all acceptance criteria.The customer's reported complaint description of patients with dvts was confirmed based on information provided by the treating physician.Although the complaint is confirmed, a root cause cannot be determined.Dvts are a known anticipated procedural complication.A review of the device history records was performed for the serial number (b)(4).The review confirms that the unit met all material, assembly, and performance specifications.A review of the service order database for the reported serial number noted that no repairs, servicing and/or upgrades have been made since the unit was manufactured.Labeling review: the user manual (man/31/0075 us version 2.0 may 2011), 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.Complaint reference (b)(4).

Manufacturer Narrative

Received for evaluation was a guidewire.The product was sent to angiodynamics' vendor of this product.They conducted an evaluation at their facility to determine a root cause and their findings are as follows; external evaluation: the supplier indicated that "the fracture was observed on the core but not on the joint of the core to the coil of the guidewire, which has never been observed during manufacturing process or wire handling".The reported complaint description of "the guidewire broke off" has been confirmed, however definitive root cause cannot be determined.Per the supplier: "the fracture was observed on the core but not in the joint of the core to the coil of the guidewire, which has never been observed during the manufacturing process or wire handling.Per the fracture's location, it might be said the issue can be material related.So, a revision if all raw materials and associated sub-assemblies were reviewed and as per record of material was within specification." 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 (ic 422) which is supplied to the end user with this catalog number contains the following statement "the micro access kit is used for percutaneous introduction of a guidewire or catheter into the vascular system following a small 21-gauge needle stick.Gain percutaneous access with the 21 ga.Entry needle.Advance the 0.018" guidewire through the 21 ga.Needle.Withdraw the entry needle while leaving the 0.018" guidewire in place.Advance the sheath/dilator set over the 0.018" guidewire.Remove the 0.018" guidewire and the inner dilator from the introducer sheath/dilator set.Advance up to a 0.038" guidewire or catheter through the introducer sheath." 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.Complaint#: (b)(4).This mdr was originally submitted february 03 2020.It failed as there was a duplicate complaint already submitted under this number.Investigation noted another mdr (reference: (b)(4) had been inadvertently sent under the same number.(b)(4) should have been sent under 1319211-2019-00113.(b)(4), 1319211-2019-00113 has been corrected and resubmitted on february 10 2020.(b)(4), is being sent as a correction.All codes and narrative are correct.The above resubmission failed again as being a duplicate report.February 12 2020, this report is being submitted again as follow up #2.The information was not removed in order to ensure it was captured.

• Brand Name: MICRO-INTRODUCER KITS
• Type of Device: MICRO-INTRODUCER KITS
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury, ny NY 12804
• MDR Report Key: 9315232
• MDR Text Key: 166530236
• Report Number: 1319211-2019-00103
• Device Sequence Number: 1
• Product Code: DQT
• UDI-Device Identifier: H787065970535
• UDI-Public: H787065970535
• Combination Product (y/n): N
• PMA/PMN Number: K051655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: H787065970535
• Device Lot Number: 5482364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 10/30/2019; 10/30/2019
• Supplement Dates FDA Received: 12/16/2019; 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention