MAUDE Adverse Event Report: ANGIODYNAMICS UNI*FUSE INFUSION CATHETER

Catalog Number	H787124018025
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2017: the patient under went a declot procedure in a fistula in an upper extremity.The procedure was successfully completed.However, as the catheter was being removed, it was noted the tip/marker band had detached inside of the patient.The tip/marker band was successfully removed with no report of permanent harm or injury to the patient.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a 45cm unifuse catheter.A visual review of the catheter noted that sample was missing the most distal marker band.The proximal band was attached and correctly located.The band measurements met dimensional specifications.The band was not cracked or split and appeared to have been swaged and embedded per manufacturing specifications.The occluding ball wire (b)(4) was able to be advanced in the catheter with no unusual resistance.The catheter tubing met all dimensional specifications.The 5f marker band also met dimensional specifications and crimp marks were visualized on the shaft of the catheter tubing.The customer's reported complaint description of a marker band detaching is confirmed.Only the distal marker band was detached.The device evaluation of the returned sample showed no manufacturing non-conformances.The catheter tubing and detached marker band met dimensional specifications.A definitive root cause for the marker band detachment cannot be determined, although the most possible root cause could be due to the patient's anatomy.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.(b)(4).

• Common Device Name: UNI*FUSE INFUSION CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6986727
• Report Number: 1319211-2017-00107
• Device Sequence Number: 19251550
• Product Code: KRA
• UDI-Device Identifier: H787124018025
• UDI-Public: H787124018025
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K951509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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: Physician
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: H787124018025
• Device Lot Number: 5119237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 02/23/2018
• 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
• Patient Age: 63 YR