MAUDE Adverse Event Report: ANGIODYNAMICS MICRO-INTRODUCER KITS

Catalog Number 06597050

Device Problem Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

The reported defective device has been returned to the manufacturer and an into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

A supply chain manager reported an issue with a stf 4f microintroducer kit 45cm.While the physician was gaining access with the microintroducer kit, the micropuncture wire became unraveled.The fully intact wire was removed from the patient's body and another same device was opened to complete the procedure.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.

Manufacturer Narrative

Returned for evaluation was a guidewire.A visual examination of the guidewire note the tip was unraveled./stretched.The guidewire is a purchased component.The vendor, haraeus, was made aware of this complaint per (b)(4).Per the vendor's investigation results: "a review of the device history records was performed for the component batches for any unusual condition related to the defect reported.The review confirms that all units were properly assembled and inspected and were sent within specification to angiodynamics.The wire was found broken on the grinded core section, which means neither the glue exchange bond nor the welding was compromised.The next observation was the glue bond section, in which it was observed the presence of glue in good condition, no breaks, or glue gaps.The shape of the cone looked good.Additionally, the glue bond diameter was measured using a go ring gauge and it was found to be within specification as per drawings requirements.The unit came with the distal end in good condition: there is the presence of the dome, the coil didn't show any deformation, the dome was properly formed and present in the wire." the customer's reported complaint description of "the micro puncture wire became unraveled" was confirmed as the returned sample shows the guidewire is unraveled.Although the complaint sample returned is confirmed to have unraveled, a definitive root cause cannot be determined.A review of the device packaging 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 instructs the user to withdraw the needling while leaving the guidewire in place.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: MICRO-INTRODUCER KITS
• Type of Device: MICRO-INTRODUCER KITS
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 10777217
• MDR Text Key: 214345795
• Report Number: 1319211-2020-00072
• Device Sequence Number: 1
• Product Code: DQT
• UDI-Device Identifier: H787065970505
• UDI-Public: H787065970505
• Combination Product (y/n): N
• PMA/PMN Number: K051655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 06597050
• Device Lot Number: 5597254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1