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

Catalog Number	H787065970045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
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 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
• Common Device Name: MICRO-INTRODUCER KITS
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury, ny
• MDR Report Key: 9939861
• Report Number: 1319211-2020-00029
• Device Sequence Number: 16882291
• Product Code: DQT
• UDI-Device Identifier: H787065970045
• UDI-Public: H787065970045
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020

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: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: H787065970045
• Device Lot Number: 5558124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/29/2020
• 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: Other