MAUDE Adverse Event Report: ANGIODYNAMICS MICRO-INTRODUCER KITS

Catalog Number H787065072125

Device Problem Knotted (1340)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/18/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the disposable device 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.(b)(4).

Event Description

As reported to angiodynamics on september 18, 2017: rn inserted wire into patient and met resistance.When the dr.Tried to withdraw the guidewire and needle, the needle came out, but the wire was stuck.The wire then began to uncoil.The patient was taken to the or to have wire removed.It was reported the wire was successfully removed via cutdown.Upon removal of the guidewire, it was noted the guidewire had knotted.It was reported there was no damage to the vessel due to the event.It was indicated the defective disposable device is not available for return to the manufacturer.

Manufacturer Narrative

As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.However, based on photographs provided by the user, the customer's reported complaint description of guidewire unraveling is confirmed.Although the complaint description is confirmed, without a device evaluation, a definitive root cause for the event cannot be determined.Angiodynamics made the supplier of this device aware of the event via (b)(4).The supplier performed a review of the lot history records, and supplied the statement: "the history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable." a packaging lot history record search was performed and revealed no quality related issues or manufacturing deficiencies at the time of packaging.The instructions for use, which is supplied to the end user with this catalog number contains the following statement "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." 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; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 6935055
• MDR Text Key: 89019135
• Report Number: 1319211-2017-00103
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: H787065072125
• UDI-Public: H787065072125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: H787065072125
• Device Lot Number: 5200028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2017
• 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