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

Catalog Number	H965457591
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	Serious Injury
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.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.Complaint # (b)(4).
Event or Problem Description
As reported: we were trying to gain access to do a fistulagram with the 5fr micro, when the floppy end of the wire broke off in the patients arm.The doctor was able to retrieve the wire via cutdown.The patient was reported as stable post procedure.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 cannot be confirmed because no sample was returned for evaluation.Without receiving product to evaluate, a definitive root cause cannot be determined.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.The instructions for use (ic 186), which is supplied to the end user with this catalog number states; "to tighten the pigtail shape, gently pull the suture until resistance is felt".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).
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 cannot be confirmed since no sample was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.The guidewire component is supplied to angiodynamics by the supplier heraeus medical components.Scar004069 was sent to the supplier, heraeus medical components for dhr review of supplier lots.As per scar004069 results, supplier heraeus medical, there was no observation made during records review that identify any contributing factors to the failure reported.All inspections results were recorded within specification limits.The product specifications were met with no non-conformities reported for manufacturing and inspection.A general training review was performed.It was verified that all personal was properly trained in all manufacturing process steps and in quality inspection as well.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: direction for use {dfu} {item number 16600601-01} contains the following statements: 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.Operational instructions 1.Prior to insertion, flush all components with saline or heparinized/saline.2.Gain percutaneous access with the 21 g (0.9 mm) vascular introducer needle.3.Advance the 0.018 inch (0.46 mm) guidewire through the needle.Caution: the guidewire should not be withdrawn through the introducer needle.If the guidewire must be withdrawn while still inside the needle, simultaneously remove both the needle and the wire as a unit to prevent the needle from damaging the guidewire.4.Withdraw the introducer needle, leaving the 0.018 inch (0.46 mm) guidewire in place.5.Advance the coaxial assembly over the 0.018 inch (0.46 mm) guidewire.6.Simultaneously remove the dilator and 0.018 inch (0.46 mm) guidewire, while holding the sheath portion of the assembly in place.7.Advance a 0.035 inch (0.89 mm) or 0.038 inch (0.97 mm) guidewire into the sheath.8.Remove the sheath, leaving the 0.035 inch (0.89 mm) or 0.038 inch (0.97 mm) wire.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).*report 1317056-2020-00024 follow up 01 contained the incorrect information, therefore this report follow up 02 is being submitted in order to report the correct data.

• Brand Name: MINI STICK MAX
• Common Device Name: VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny
• MDR Report Key: 9740543
• Report Number: 1317056-2020-00024
• Device Sequence Number: 1802280
• Product Code: DRE
• UDI-Device Identifier: H965457591
• UDI-Public: H965457591
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2020

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: 11/30/2022
• Device Catalogue Number: H965457591
• Device Lot Number: 5557204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 01/31/2020; 01/31/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 04/13/2020; 04/23/2020
• 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: Required Intervention
• Patient Age: 85 YR