MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number 10303818

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

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

Event Date 11/02/2021

Event Type  malfunction  

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 investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

An end user reported an issue with a guidewire when using a dialysis with bioflo chronic dialysis catheter 15.5f 24cm single valve sheath vascpak kit.A guidewire is not supplied with this kit and is of unknown brand.The guidewire was kinked during dilator exchanges.Md noted resistance when advancing the dilator under fluoro.The doctor noticed, under flouro, that the guidewire was frayed.It was noted, on fluoro, that the inner structural wire of the guidewire was exposed while inside the body.The entire wire was retrieved/pulled back into the dilator and removed from body.It was confirmed that no part of the device fragmented off inside the patient.The patient denied any complaints of chest pain or shortness of breath.Once the wire was removed, examination of the distal end of the dilator was noted to have fractures/fissures/cuts after removal from body.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.

Manufacturer Narrative

Returned for evaluation was one sheath and a guidewire.As received, the sheath tip and guidewire are damaged.The guidewire returned with the sheath is of unknown origin.No guidewire is supplied to item number {h965103038181}.The guidewire has core wire protruding through the coils.The tip of the sheath was damaged, likely due to the damaged/unraveled guidewire; i.E.When trying to withdraw damaged guidewire through the dilator tip.The customer's complaint description is confirmed for damaged sheath.The customer returned a guidewire of unknown origin/manufacturer, however, it was determined that angiodynamics did not supply/distribute this guidewire to the customer.The guidewire was damaged by having core wire protrude from the guidwire coils.This damaged guidewire caused damaged to the dilator tip when guidewire was likely attempted to be withdrawn from dilator.Root cause of dilator tip is handling damage during use.A review of the device history records was performed for the indicated lots for any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.Review of bom for packaged good item number h965103038181 shows that no guidewire accessory device is provided with the bioflo dialysis catheter device.A ship history report for customer account 23238 was performed for the 3 year period prior to the procedure date and angiodynamics has not shipped any single sterile guidewire packaged good items to the customer.The manufacturer of the guidewire cannot be determined as it was not distributed to the customer by angiodynamics labeling review: the following is provided as a reference from the dfu: caution: do not pull apart the portion of the sheath that remains in the vessel.To avoid vessel damage, pull back the sheath as far as possible and tear the sheath only a few centimeters at a time.Warnings: do not advance the guidewire or catheter if unusual resistance is encountered.Do not insert or withdraw the guidewire forcibly from any component.The wire may break or unravel.If the guidewire becomes damaged, the introducer needle or sheath introducer and guidewire must be removed together.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 DIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 12919047
• MDR Text Key: 281744178
• Report Number: 1317056-2021-00195
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: H965103038181
• UDI-Public: H965103038181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 10303818
• Device Lot Number: 5649864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2020
• 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 Age: 46 YR
• Patient Sex: Male