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

Catalog Number	45881
Medical Device Problem Codes	Stretched (1601); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A clinical specialist reported an end user experienced an issue with a picc from a bio-stable picc (valved) 4f sl 55cm ir-145 kit, with nitinol gw.The patient had a picc insertion in (b)(6) 2023.Uses it every 4-6 hours for meds.It was put in at a certain length that was where it needed to be and the appropriate 3cm from skin on the outside of the patient for the securement device.She came back to the hospital for issues with chest pain/enzyme elevation issues.With some imaging it showed that the picc was sitting well in the right ventricle.Due to this issue, the picc was removed and replaced with a new one, which was cut 1cm shorter than the original picc's length to be safe.The tubing on the removed picc, at the part that was inside the patient, was noted to be a slightly different color than the portion that was outside the patient.It was also thought to have "felt differently".The picc was measured against a measuring tape, measuring 46 cm even though it was cut at 40cm according to the markings.It seems to have stretched considerably and that stretching has caused some patient issues.The patient was reported as stable after the picc was removed and replaced.
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
Returned for evaluation was one (1) catheter.As received, the catheter was returned in two pieces.Engineering evaluation: the complaint of picc stretching is confirmed.However, the measured 0.8 cm stretch on the sample returned is less than the reported 6 cm stretch.The picc most likely stretched during removal.The catheter measured within specification for id and od.The customer's reported complaint description of catheter became "stretched" was confirmed based on visual and dimensional inspection of the returned complaint sample.As noted, the likely root cause of the catheter dimensions being longer than the printed markings is due to stretching of the catheter tubing during the removal process.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 in the reported kit is item number (b)(6).The dfu states that fibrin sheath formation is a potential complication/adverse advent.Potential complications/adverse events: fibrin sheath formation.Patients must be educated regarding the care and maintenance of their picc.The healthcare provider is responsible for this patient instruction.Note: strict aseptic technique must be used during insertion, routine maintenance and removal procedures.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.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.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: 18255298
• Report Number: 1317056-2023-00168
• Device Sequence Number: 15230957
• Product Code: LJS
• UDI-Device Identifier: H965458810
• UDI-Public: H965458810
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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: 04/30/2025
• Device Catalogue Number: 45881
• Device Lot Number: 5777181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female