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

Catalog Number	H787065072015
Health Effect - Clinical Code	Cardiogenic Shock (2262)
Date of Event	10/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The disposable device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
Medwatch report mw5090799 was received november 18 2019.No identifying customer information was provided.On (b)(6) 2019, a patient with critical as was taken to the cath lab s/p cardiac arrest and ecmo placement for right heart cath, and placement of arterial line, swan-ganz (sg) catheter, and retrograde reperfusion cannulas.Advancement of the sg microwire was a bit difficult and faced with resistance.The wire was drawn back and able to be pulled out of the needle but it came out frayed.At that point, the decision was made to withdraw the remaining wire and needle in one fashion.Consultation with interventional cardiology, critical care physician and interventional radiology, and cardiothoracic surgery occurred.It was determined that this was a short tip of the platinum wire in the venous system and that at the current state, given the patient's cardiogenic shock, ecmo status, that no further intervention would be done at that time.The defective disposable device is not available for return to the manufacturer.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics was unable to perform a device evaluation.The customer's reported complaint description of "the wire was drawn back and able to be pulled out of the needle but it came out frayed", could not be confirmed because no sample was returned.Without receiving a sample for evaluation, we are unable to definitively determine a root cause for this incident.Although no sample was returned, it was stated that the customer drew back the wire through the needle, per the ifu it states, "withdraw the entry needle while leaving the.018" guidewire in place".A possible root cause to this complaint is most likely due to end user pulling the guidewire out of the needle (as indicated in the event description).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 (ic 182), which is supplied to the end user with this catalog number instructs the user to 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.Reprocessing may compromise the integrity of the device and / or lead to device failure." 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
• Common Device Name: MICRO-INTRODUCER KITS; GUIDEWIRE
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 9415580
• Report Number: 1319211-2019-00112
• Device Sequence Number: 2424527
• Product Code: DQX
• UDI-Device Identifier: H787065072015
• UDI-Public: H787065072015
• 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: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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 Expiration Date: 07/31/2022
• Device Catalogue Number: H787065072015
• Device Lot Number: 5495035
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 02/03/2020
• 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: Required Intervention