MAUDE Adverse Event Report: ANGIODYNAMICS, INC MICRO-INTRODUCER KITS

Catalog Number	06597014
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
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 of guidewire dislodged into patient's abdomen cannot be confirmed due to no sample was returned for evaluation.Without receiving product to evaluate, a root cause cannot be determined.A possible root cause of the guidewire breaking off in patient's abdomen could be user error, it's possible that the user could have pulled guidewire back through the access needle.It is stated in the ifu: "withdraw the entry needle while leaving the 0.018" guidewire in place." 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: the instructions for use which is supplied to the end user with this catalog number contains the following statement "the micro-introducer is designed for percutaneous introduction of a guidewire or catheter into the vascular system utilizing a 21 gauge needle stick.Gain percutaneous access with the 21 gauge needle.Advance the 0.018" guidewire through the 21 gauge needle.Withdraw the entry needle while leaving the 0.018" guidewire in place.Advance the micro-introducer over the 0.018" guidewire.Remove the 0.018" guidewire and the micro-introducer inner dilator.Advance up to a 0.038" guidewire or catheter through the micro-introducer sheath.Remove micro-introducer sheath." 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).
Event or Problem Description
A director of risk management reported that an ir physician assistant attempted an ultrasound guided paracentesis, accessing the right upper quadrant, with a std 5f m.I.Kit.While attempting to gain access into the peritoneal space, a small portion of the 018 guidewire dislodged into the patient's abdomen.The dislodged portion was not removed as it was lodged in tissue and the guidewire was not retained.

• Brand Name: MICRO-INTRODUCER KITS
• Common Device Name: MICRO-INTRODUCER KITS
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury, ny
• MDR Report Key: 10048575
• Report Number: 1319211-2020-00031
• Device Sequence Number: 2849012
• Product Code: DQT
• UDI-Device Identifier: H787065970145
• UDI-Public: H787065970145
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/12/2020

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 Catalogue Number: 06597014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 05/12/2020
• 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: Other
• Patient Age: 54 YR