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

Catalog Number H787065970045

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

The reported defective device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).

Event Description

Fda medwatch reference mw5093078 was received on march 26 2020.The food and drug administration reported that a risk manager, from (b)(6) hospital, submitted a sus voluntary event report for our 5f standard micro-introducer kit.The report states that a piece of the micro-introducer broke during an interventional radiology procedure.It was reported by the end user that the patient experienced a serious injury.It was reported the defective disposable device is available for return 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 is not confirmed.The sample was not returned, without a sample for evaluation a definitive root cause cannot be determined.Angiodynamics' supplier of this device was notified of the event via (b)(4).Per the supplier response: "root cause could not be determined.Review of the manufacturing records did not reveal any discrepancies that would have contributed to this event.Device was not returned for analysis.This complaint is non-verifiable." 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.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
• MDR Report Key: 9939861
• MDR Text Key: 206865042
• Report Number: 1319211-2020-00029
• Device Sequence Number: 1
• Product Code: DQT
• UDI-Device Identifier: H787065970045
• UDI-Public: H787065970045
• 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,use
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: H787065970045
• Device Lot Number: 5558124
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other