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

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/27/2018

Event Type  Injury  

Manufacturer Narrative

No device history records review was conducted since there was no reported lot # and ship history lot review was not performed since item # is unknown.The recent angiodynamics complaint report was reviewed for the insertion kits product family and the failure mode "guidewire fractured." no adverse trend was identified.As no sample was returned, no device evaluation is possible and the relationship between the device and the reported event is unable to be determined.While it is possible that the end user damaged the guidewire by pulling it back against a needle cannula, this cannot be confirmed.The directions for use (dfu) packaged with the mini stick max contains the following cautions: "do not withdraw guidewire through metal needles: guidewire may shear or unravel.If any obstruction is met, then do not attempt to remove guidewires over the needle or other metal instrument.Obstruction might occur during insertion and lead to tangled coiled part of the wire then difficulty to remove it through tip of the sheath." and "warnings: do not rotate the guidewire if significant resistance is felt".(b)(4).

Event Description

During a right upper extremity fistulagram, the 0.18" guidewire from a mini stick max coaxial microintroducer kit frayed during attempted access with a "small" fragment of wire detaching and remaining in the patient.The wire fragment was not removed.The guidewire sample will not be returned to angiodynamics - it was turned over to biomed and legal at the hospital.

• Brand Name: ANGIODYNAMICS / MINI STICK MAX
• Type of Device: 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: law ryan ; 10 glens falls technical park; glens falls, NY 12801
• MDR Report Key: 7822011
• MDR Text Key: 118394786
• Report Number: 1317056-2018-00165
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR