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

Catalog Number	H965457561
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/09/2019
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.(b)(4).
Event or Problem Description
During a port placement procedure, the treating physician was placing a routine port into the patient, accessing the vein using angiodynamics' micro introducer kit, mini stick max.After access was gained, dr (b)(6) went to remove the sheath/dilator and found that the sheath had detached from the hub while inside the patient.The sheath then traveled to the patient's heart and ended up in the rv.The sheath was removed using a snare, and the patient is stable and doing well.It was reported the defective disposable device is available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics was unable to perform a device evaluation.The end user did supply a photograph of the defective device for review.The customer's reported complaint description is confirmed based on the photograph, however without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.The 5f introducer is a purchased accessory from supplier medron.Angiodynamics' supplier of this product was notified per scar003986 and a copy of the photograph was sent to the supplier, medron for evaluation, root cause determination, dhr review of supplier lot {430258} and corrective action.Medron's review of the photo confirmed that the sheath tubing pulled out of the molded hub.The most likely root cause of the short step 2 above one of the extrusions loaded on the core pin was jostled so its position moved on the core pin from the designed location out to a position that would result in a short capture.Root cause was determined to be tubing was not inserted far enough into hub mold.Medron's correction/corrective actions: instruction/training the manufacturing procedure that demonstrates the proper procedure for mini stick sheath molding is being updated with clarifying pictures and instructions that will further demonstrate acceptable and improperly loaded extrusions on core pins.As well as clarifying that this step to verify the extrusion have been loaded properly must be performed when the cassette has been loaded into the mold.All mold operators will be trained to these updates.Medron's post molding verification: flexan is implementing a post step that will detect any extrusion that may not have achieved the proper "captured length".This will be done in the form of a length inspection go/no go fixture.The cassette with molded parts will immediately be placed on the fixture after molding.Any parts that have an insufficient capture will have extrusion that are longer than the length fixture allows.These parts will be rejected.Capa (b)(4).As a corrective action to address hub separation from introducer.A review of angiodynamics' 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.Angiodynamics' labeling review: directions for use (dfu) 16600601-01.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.Labeling review: directions for use (dfu) 16600601-01.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 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 FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 9152545
• Report Number: 1317056-2019-00124
• Device Sequence Number: 11515170
• Product Code: DRE
• UDI-Device Identifier: H965457561
• UDI-Public: H965457561
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2020

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: 07/31/2022
• Device Catalogue Number: H965457561
• Device Lot Number: 5497862
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 01/23/2020
• 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: 40 YR