MAUDE Adverse Event Report: ANGIODYNAMICS MICRO-INTRODUCER KITS

Catalog Number 06597022

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

Angiodynamics received a user medwatch.The report did not contain any identifying end user information.Per the report: patient underwent routine pre-transplant heart cath with biopsy.While attempting to obtain access in the right femoral vein, the micro-introducer wire became lodged in the soft tissue of the group.While attempting to remove the wire, the distal tip (<2mm) of the wire was dislodged.The wire was not flow-limiting and retrieval was not attempted.It is unknown the health status of the patient.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.

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 "the micro-introducer wire became lodged in the soft tissue of the group" is not confirmed; no sample was returned.Without receiving a sample for evaluation a root cause for this event could not be determined.A potential root cause is customer pulling guidewire back through and against needle, which is cautioned against in dfu.Scar004289 was sent to guidewire supplier heraeus medical for review of dhr of affected lot number."reviewing complaints of the last 12 months it was found this is the first occurrence of this issue in hmcr (heraeus medical components costa rica) facility for this part number and batches reported, therefore there is no identified trend on this.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, 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.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

Manufacturer Narrative

Correction: it was reported as a serious injury.Changed to malfunction.Reference (b)(4).

• Brand Name: MICRO-INTRODUCER KITS
• Type of Device: MICRO-INTRODUCER KITS
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 11528411
• MDR Text Key: 241020900
• Report Number: 1319211-2021-00018
• Device Sequence Number: 1
• Product Code: DQT
• UDI-Device Identifier: H787065970225
• UDI-Public: H787065970225
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 06597022
• Device Lot Number: 5645484
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention