MAUDE Adverse Event Report: ANGIODYNAMICS MICRO-INTRODUCER KITS

Catalog Number	H787065970045
Medical Device Problem Code	Knotted (1340)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/16/2017
Type of Reportable Event	Serious Injury
Additional 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.(b)(4).
Event or Problem Description
As reported to angiodynamics on december 05, 2017: per user medwatch (b)(4) received: the patient was admitted with diagnosis svt for ablation svt, eps with 3d mapping.While the physician was obtaining venous access to the patient's left femoral vein, the ministick wire inadvertently became knotted up and stuck in the subcutaneous tissue.The position of the wire was unchanged at the end of the study.The patient's parents were notified.Another doctor was consulted; no need to remove the piece of wire.The procedure was completed; the patient was discharged the next day.It was reported the defective disposable device is not available for return to the manufacturer.
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of "guidewire fractured and migrated" could not be confirmed as the deective device was not returned for evaluation.Without a device evaluation, angiodynamics is unable to determine a root cause for the reported complaint description.Although no sample was returned, the most likely root causes for this event would be due to the patient's anatomy or physician's technique, i.E.Pulling guidewire back through the needle.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, instructs the user to 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.Reprocessing may compromise the integrity of the device and / or lead to device failure." 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 # pr17728.

• Brand Name: MICRO-INTRODUCER KITS
• Common Device Name: MICRO-INTRODUCER KITS
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7156789
• Report Number: 1319211-2018-00002
• Device Sequence Number: 13698132
• Product Code: DQT
• UDI-Device Identifier: H787065970045
• UDI-Public: H787065970045
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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
• Operator of Device: Physician
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: H787065970045
• Device Lot Number: 5243426
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 03/23/2018
• 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: Required Intervention
• Patient Age: 8 YR