MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; INTRODUCER, CATHETER

Model Number	06597052
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An end user reported an issue with a stf 4f m.I.Kit 45cm nt/t echo s.During a procedure, the introducer broke inside of the patient.No further details were provided.
Additional Manufacturer Narrative
The device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
Returned for evaluation was a 4f coaxial micro-introducer sheath.As received the returned sheath was in two pieces with a separation of the sheath tubing ~1.5cm distal from the hub.Scar 004842 and the returned sample were sent to the supplier, greatbatch for sample evaluation/root cause determination and dhr review of the reported lot.Per scar0 04842 response, dhr review did not reveal any discrepancies that would have contributed to this event.Visual analysis on the returned device revealed a mark/cut that was likely caused by a tool outside of coax package.No manufacturing non-conformance observed during evaluation of the returned device.The customer's reported complaint description is confirmed for sheath tubing detached; tubing was sliced (by sharps) with indications of being pulled to failure.Although the reported complaint description is confirmed, a definitive root cause for the event cannot be determined.A review of previously reported complaints and investigations for this failure mode for this sheath device revealed that a potential root cause is the tubing being nicked by sharp instrument (e.G.Scalpel) and then tubing pulled to failure during sheath removal (pulling on hub).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: the instructions for use which is supplied to the end user with this catalog number contains the following statements: intended use the micro access kit is used for percutaneous introduction of a guidewire or catheter into the vascular system following a small 21-gauge needle stick.Potential complications · perforation of a vessel or viscus · laceration of a vessel or viscus · embolism instructions for use 1.Gain percutaneous access with the 21 gauge needle.2.Advance the 0.018" guidewire through the 21 gauge needle.3.Withdraw the entry needle while leaving the 0.018" guidewire in place.4.Advance the micro-introducer over the 0.018" guidewire.5.Remove the 0.018" guidewire and the micro-introducer inner dilator.6.Advance up to a 0.038" guidewire or catheter through the micro introducer sheath.7.Remove micro-introducer sheath.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.(b)(4).
Additional Manufacturer Narrative
**udi related data quality updates only** the information in this report has been corrected to match the data submitted in global unique device identification database (gudid).Reference (b)(4).Corrections: d4 : model number, expiration date, udi.

• Brand Name: ANGIODYNAMICS
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 603 queensbury avenue; queensbury, NY 12804 ; 5086587990
• MDR Report Key: 17907100
• Report Number: 1319211-2023-00070
• Device Sequence Number: 20466089
• Product Code: DYB
• UDI-Device Identifier: H787065970520
• UDI-Public: H787065970520
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2024
• 2 Devices were Involved in the Event: 1 2

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: 05/31/2026
• Device Model Number: 06597052
• Device Catalogue Number: 06597052
• Device Lot Number: 5789297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2023
• Supplement Date Received by Manufacturer: 11/09/2023; 07/11/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/17/2023; 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• 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: 13 YR
• Patient Sex: Male