MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number	75019
Medical Device Problem Codes	Complete Blockage (1094); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An end user reported an issue with a picc from a bioflo picc (valved) 5fdl-55cm maximal barrier nursing kit.The patient's catheter was removed due to it not functioning as intended.Upon examining the removed picc, it was noted the catheter line was occluded.The patient did not experience any adverse effects or harm due to this incident.
Additional 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).
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of picc device was occluded cannot be confirmed since no complaint sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Potential contributing factor for an occluded picc that is in situ is inadequate flushing that results in thrombosis and/or fibrin sheath formation.Since picc was placed and in use for 3 weeks before occlusion was observed, a manufacturing related device non-conformance is unlikely to have contributed to the occlusion issue.Prior to being placed in the tray, the catheter is 100% inspected at the top-assembly and sub-assembly levels to ensure lumen patency.Dhr review of the packaging/assembly lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.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 AND PASV VALVE TECHNOLOGY
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• 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: 17644478
• Report Number: 1317056-2023-00116
• Device Sequence Number: 5970490
• Product Code: LJS
• UDI-Device Identifier: H965750191
• UDI-Public: H965750191
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2024
• Device Catalogue Number: 75019
• Device Lot Number: 5763960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 66 KG