MAUDE Adverse Event Report: ANGIODYNAMICS MINI STICK MAX; VESSEL DILATOR

Catalog Number	H965457531
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint # (b)(4).
Event or Problem Description
As reported: ministick max used to access the femoral artery, at some point the shaft separated from the body and was retained inside the artery.The surgeon had to cut down femoral artery to remove the broken piece.Patient sustained no injuries.They were able to proceed with the procedure with no major adverse injury to patient.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a used introducer 4f.As received, 4f introducer in two pieces.The returned sample was sent to angiodynamics' supplier of this product for evaluation, root cause determination, dhr review of supplier lot and corrective action.The customer's reported complaint description is confirmed.Per the supplier's response, a review of the returned sample under magnification confirmed that 3 sharp angled cuts in the tubing ranging from 0.5" - 0.75" from the hub.The sharp cuts would indicate a scalpel or other very sharp blade.The cuts would not have occurred in any of the manufacturing process at flexan.It is believed that a scalpel or other sharp device used during the medical procedure may have caused failure.The directions for use for this product states: warning: contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged.If damage is found, call your navilyst medical representative.Inspect prior to use to verify that no damage has occurred in shipping.For single patient use only.Do not reuse, reprocess or resterilize.Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death.Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.Contamination of the device may lead to injury, illness or death of the patient.After use, dispose of product and packaging in accordance with hospital, administrative and or local government policy.Device description.The mini stick* max coaxial microintroducer kit contains: (1) coaxial sheath/dilator assembly; (1) 21 g (0.9 mm) vascular introducer needle; and (1) 0.018 inch (0.46 mm) floppy tip guidewire.Intended use/ indications for use.The coaxial microintroducer kit is used for the percutaneous introduction of a guidewire into the vascular system.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: MINI STICK MAX
• Common Device Name: VESSEL DILATOR
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8932201
• Report Number: 1317056-2019-00112
• Device Sequence Number: 253739
• Product Code: DRE
• UDI-Device Identifier: H965457531
• UDI-Public: H965457531
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K132713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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: 10/31/2021
• Device Catalogue Number: H965457531
• Device Lot Number: 5396571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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: Required Intervention
• Patient Age: 84 YR