MAUDE Adverse Event Report: ANGIODYNAMICS, INC UNI*FUSE INFUSION CATHETER; UNI*FUSE INFUSION CATHETER,

Catalog Number	H787124018165
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint # (b)(4).
Event or Problem Description
Patient had a right dvt.A unifuse system was used to dissolve thrombosis.After 5 days, the catheter was found broken when it was removed from the body.The catheter fragment was successully removed.The catheter was replaced with a new of the same device to complete the treatment of the dvt.The patient did not suffer any harm or injury due to this event.It was reported the defective disposable device is available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was an occluded unifuse guidewire.A visual of the guidewire noted the guidewire tip end (coiled tip) was separated from the guidewire mandrel.The customer's reported complaint description was confirmed; the occlusion guidewire was observed to have tip separated from the mandrel wire.The root cause of the tip detachment could not be definitively determined.A possible root cause for the occluding guidewire separating could be due to handling damage.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: warning: never advance the guidewire against resistance; this could cause vessel trauma and/or wire damage.Determine the cause of resistance under fluoroscopy and take any necessary remedial action.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).

• Common Device Name: UNI*FUSE INFUSION CATHETER,
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 8845466
• Report Number: 1319211-2019-00069
• Device Sequence Number: 16676481
• Product Code: KRA
• UDI-Device Identifier: H787124018165
• UDI-Public: H787124018165
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K951509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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: 03/31/2022
• Device Catalogue Number: H787124018165
• Device Lot Number: 5429035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 10/24/2019
• 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