MAUDE Adverse Event Report: ANGIODYNAMICS XCELA POWER INJECTABLE PICC; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number 60M701532

Device Problem Material Discolored (1170)

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

Event Date 08/18/2023

Event Type  malfunction  

Manufacturer Narrative

The reported device has been returned to the manufacturer and an investigation 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

An end user reported an issue with a can 5f dual xcela picc.It was reported that, during visual inspection, one lumen of the picc was noted to be cloudy yellow.There is also a "homogenous cloudiness" throughout the visible portion of the catheter.The picc was in situ for approximately 8 months before it was removed and replaced.The patient did not experience any adverse effects, harm, or require medical intervention because 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 5f dual lumen xcela pasv picc.As received, the customers complaint description is confirmed for lumen discoloration.The extension tubing had a frosted like appearance.Also noted the catheter tubing appeared pinkish in color.The extension tubing was sectioned, and it was observed that a sticky film was present on the inside surface that could be wiped off with isopropyl alcohol, leaving the extension tubing clear with no evidence of degradation.The composition of this film is unknown, however, based upon the absence of any damage to the extension tubing underneath the film, it appears to be a residue or precipitate from the infused drugs.Based on the sample analysis, this device did not malfunction.It is possible that the film observed on the id of the extension tubes was the result of instability of the etoposide mixture used/infused causing the drug to precipitate from solution as the observed film.The customer's reported complaint description of cloudy extension tubing is confirmed based on evaluation of returned picc complaint sample.The likely root cause for the discoloration is drug precipitate.This is an issue of customer use of the picc for a specific patient population drug therapy and not a picc device malfunction.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.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.(b)(4).

• Brand Name: XCELA POWER INJECTABLE PICC
• Type of Device: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• MDR Report Key: 12475954
• MDR Text Key: 271522289
• Report Number: 1317056-2021-00165
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: H96560M7015321
• UDI-Public: H96560M7015321
• Combination Product (y/n): N
• PMA/PMN Number: K070002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60M701532
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Date Manufacturer Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1