MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO PICC WITH ENDEXO TECHNOLOGY; BIOSTABLE PICC

Model Number 45872

Device Problems Stretched (1601); Infusion or Flow Problem (2964)

Patient Problem Swelling/ Edema (4577)

Event Date 03/28/2023

Event Type  malfunction  

Event Description

During the insertion procedure of a picc from a bio-stable 5f dl-55cm ir-145 kit non-valved kit, under fluoroscopic and guide-wire assistance, the provider was unable to retrieve the catheter that was threaded over the wire.After multiple manipulations, the guidewire was able to be retrieved, leaving the catheter successfully insitu.The next day, the patient presented with a complaint of swelling at the picc insertion site at the left cubital fossa.The catheter was then removed due to reduce flow rate in both lumens and the worsening swelling.It was suspected catheter was overstretched or leaking.Upon inspection of the removed catheter, it was noted the mid-portion of the catheter was stretched out and defective.

Manufacturer Narrative

The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Manufacturer Narrative

Returned for evaluation was one (1) dual lumen bioflo picc.The catheter was checked for leaks and no leaks were detected.No manufacturing non-conformances were observed during sample review and the catheter met dimensional specifications.The customer's complaint description of reduced flow rate was confirmed due to the catheter being partially occluded with bio matter.The catheter tip as received was observed to be occluded with bio-matter and may be a contributing factor to the reduced flow observed during device use.The root cause for the patient's reported swelling issue could not be determined as the returned picc device showed no leaks.The customer's experience with this picc device could not be definitively determined.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.Labeling review: the dfu (directions for use) that is supplied with this picc device contains the following directions for catheter care/ maintenance: - flush the catheter after every use, or at least every seven days when not in use, to maintain patency.Use a 10 ml syringe or larger.- flush the catheter with a minimum of 10 ml of sterile normal saline, using a "pulse" or "stop/start" technique.Precaution: if resistance is met when flushing, it is recommended that no further attempts be made.Further flushing may result in catheter rupture.Refer to institutional protocol for clearing occluded catheters.Precaution: never forcibly flush an obstructed lumen.If either lumen develops a thrombus, first attempt to aspirate the clot with a syringe.If aspiration fails, consult institutional protocol for management of thrombosis.Avoid sharp or acute angles during insertion which may compromise catheter functionality.Catheter maintenance it is recommended that institutional protocols be followed for all aspects of catheter care, use and maintenance.The following care, use and maintenance information is not intended as a substitute for institutional protocol, but rather, to describe guidelines and recommendations that can be used successfully with the bioflo picc with endexo and pasv valve technology.General catheter care and use · use aseptic technique during catheter care and use.· use standard and universal precautions during catheter care procedures.· never leave catheter uncapped.· do not use clamps, or instruments with teeth or sharp edges on the catheter, as catheter damage may occur.Potential complications/adverse events catheter occlusion catheter malfunction 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: BIOFLO PICC WITH ENDEXO TECHNOLOGY
• Type of Device: BIOSTABLE PICC
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 16771837
• MDR Text Key: 313815316
• Report Number: 1317056-2023-00051
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: H965458720
• UDI-Public: H965458720
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K131038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45872
• Device Catalogue Number: 45872
• Device Lot Number: 5761741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Male