MAUDE Adverse Event Report: ANGIODYNAMICS STANDARD MICRO INTRODUCER KIT

Catalog Number 06507204

Device Problems Break (1069); Missing Value Reason (3192)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 09/02/2015

Event Type  Injury  

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 device evaluation will be sent via a follow up medwatch.A review of the device history records was performed for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.(b)(4).

Event Description

As reported on (b)(6) 2015, patient of unknown age and gender presented for a unknown procedure.During the procedure, the treating physician was unable to advance the guidewire through the access needle.The physician made three unsuccessful attempts, when on the third attempt, the guidewire tip fractured off from the guidewire inside of the patient.There was no report of permanent harm or injury to the patient due to the event.Angiodynamics is attempting to obtain additional information as to the event and the patient well-being.The device was reported as not available for return to the manufacturer for evaluation as it was disposed of by the user.User medwatch mw5057355.

Manufacturer Narrative

As the reported complaint sample was disposed of by the user and not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of guidewire fracturing cannot be confirmed because no sample was returned for evaluation.Although the exact root cause of the event is unable to be determined, it does not appear to be the result of a manufacturing or design failure.A potential contributing factor may be the guidewire was pulled back against the needle and tortuous patient anatomy.A review of the device history records was performed 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, supplied to the end user states: "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." 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.(b)(4).

• Brand Name: STANDARD MICRO INTRODUCER KIT
• Type of Device: MICRO INTRODUCER KIT
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 03 queensbury avenue; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 5350435
• MDR Text Key: 35346203
• Report Number: 1319211-2015-00388
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 06507204
• Device Lot Number: 4805885
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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 Outcome(s): Required Intervention