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

Catalog Number H787065970525

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/17/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.Complaint # (b)(4).

Event Description

Venus access on a patient using 4f stiff micro introducer kit.While they were putting the introducer on the wire, it (the introducer) appeared to have sheared off of at the tip.The treating physician was unable to remove the tip from the patient's subcutaneous tissue.It was reported that the patient suffered no serious harm or injury due to this event.It was reported the defective disposable device is not available for return to the manufacturer as it was disposed of by the user.

Manufacturer Narrative

As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.Without a device evaluation, angiodynamics is unable to confirm the reported complaint description or to determine a root cause.Angiodynamics' supplier of this device was made aware of the incident.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.The instructions for use, which is supplied to the end user with this catalog number, lists perforation of a vessel or viscus, laceration of a vessel or viscus, extravasation, nerve damage, and embolism as potential complications.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).

• Brand Name: MICRO-INTRODUCER KITS
• Type of Device: MICRO-INTRODUCER KITS
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 8670488
• MDR Text Key: 147056043
• Report Number: 1319211-2019-00048
• Device Sequence Number: 1
• Product Code: DQT
• UDI-Device Identifier: H787065970525
• UDI-Public: H787065970525
• Combination Product (y/n): N
• PMA/PMN Number: K051655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H787065970525
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR