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

Catalog Number	45750
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
During a procedure, using a sheath from a mini stick max 4f x 10 cm std.018 ni/tu echo 2.75" kit, it was reported that 8cm of the sheath broke off into patient.The fragment was located in the right arm (fistula).The fragment was removed via 7fr snare.The sheath potentially broke off due to being bent and breaking in half.The procedure was completed the following day with another kit.The patient did not experience any adverse impact due to this issue.
Additional Manufacturer Narrative
Returned for evaluation was a partial sample of 4f coaxial introducer sheath.As received, the part of the sheath tubing was detached from the hub; tubing with fractured end was jagged with noted stretching.The sheath/dilator introducer accessory device is supplied to angiodynamics by the supplier/manufacturer medron llc.Scar004742 was sent to medron llc for awareness of this event, sample evaluation/root cause determination and dhr review of supplier lot (3967279, 3967280).As per scar004742 response, the review of the dhr demonstrated compliance and conformance to applicable procedures and specifications.No manufacturing defect was identified during evaluation of the complaint sample.Handling damage and procedural factors are probable cause of this incident.The customer's complaint description is confirmed for sheath tubing detached; tubing was fractured with indications of being pulled to failure.Handling damage and procedural factors are probable root cause of this incident.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: direction for use (dfu) is provided with this mini stick coaxial micro introducer.The failure mode of device fracture and embolization is cautioned as potential adverse event.No sample was returned for evaluation so it cannot be determined if device was used in a manner inconsistent with labeling.Adverse events guidewire shearing, fracture or embolization 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 adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (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
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 16932472
• Report Number: 1317056-2023-00062
• Device Sequence Number: 12266392
• Product Code: DRE
• UDI-Device Identifier: H965457501
• UDI-Public: H965457501
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 45750
• Device Lot Number: 5772169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 07/30/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 83 KG