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

Catalog Number	H787124018025
Medical Device Problem Codes	Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.To date, the device has yet to be returned.Attempts are being made to obtain the device.An investigation into the root cause for incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.Complaint reference (b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2017: during an infusion procedure, it was noted the marker band had slipped off the catheter and into the patient.The physician was able to successfully remove the marker band from the patient via a snare.There was no harm or injury to the patient due to the event.It was reported that the disposable device is available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a 45cm uni*fuse catheter.A visual review of the catheter noted the sample is missing the most distal marker band.Crimp marks were visualized on the shaft of the sample.The customer's reported complaint description of a marker band detaching is confirmed.Although the reported complaint description is confirmed, a definitive root cause for the event cannot be determined.It does not appear to be manufacturing related.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 marker bands are 100% inspected during the manufacturing process.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; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6716902
• Report Number: 1319211-2017-00076
• Device Sequence Number: 1858612
• Product Code: KRA
• UDI-Device Identifier: H787124018025
• UDI-Public: H787124018025
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K951509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2017

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: 08/31/2019
• Device Catalogue Number: H787124018025
• Device Lot Number: 5083772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 06/01/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 07/17/2017
• 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