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

Catalog Number H787065072125

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/02/2019

Event Type  Injury  

Manufacturer Narrative

The reported device is being retained by the end user for an internal investigation.Angiodynamics is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the investigation and root cause determination will be sent via a follow up medwatch.Complaint # (b)(4).

Event Description

Customer reported a significant section of the morpheus ct guidewire (11 cm) broke off during a procedure causing a patient to have to go into emergency or surgery to remove the piece.Guidewire and catheter were placed in periappendiceal abscess in rlq of abdomen.As guidewire was being removed, floppy tip of wire sheared off and remained in patient.Surgery removed guidewire piece and patient was stable afterwards.It was reported the defective disposable device is not available for return to the manufacturer.

Manufacturer Narrative

As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The end user provided a photograph od the defective device.The customer's reported complaint description of "guidewire broke off in patient" is confirmed based on photographic evidence supplied by the end user.Although the complaint description is confirmed, a definitive root cause for the event cannot be determined.A possible root cause could have been the device was forced against resistance, excessive force used, device used at sub optimal indications, operational context, inexperienced user" could have an impact on this event." a possible root cause of the guidewire breaking in the patient could be user error, or it is 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.The instructions for use, which is supplied to the end user with this catalog number, contains the following statement "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.Gain percutaneous access with the 21 ga.Entry needle.Advance the 0.018" guidewire through the 21 ga.Needle.Withdraw the entry needle while leaving the 0.018" guidewire in place.Advance the sheath/dilator set over the 0.018" guidewire.Remove the 0.018" guidewire and the inner dilator from the introducer sheath/dilator set.Advance up to a 0.038" guidewire or catheter through the 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).

• Brand Name: MICRO-INTRODUCER KITS
• Type of Device: MICRO-INTRODUCER KITS
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 8286810
• MDR Text Key: 134413878
• Report Number: 1319211-2019-00007
• Device Sequence Number: 1
• Product Code: DQT
• UDI-Device Identifier: H787065072125
• UDI-Public: H787065072125
• Combination Product (y/n): N
• PMA/PMN Number: K051655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: H787065072125
• Device Lot Number: 5232811
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention