MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO MIDLINE; MIDLINE CATHETER

Device Problem Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/09/2022

Event Type  malfunction  

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.(b)(4).

Event Description

An angiodynamics clinical specialist reported an issue with a bioflo midline 4f sl-20cm max barrier drape kit.During a midline insertion training procedure, the needle was placed in the cephalic vein, under ultrasound.Blood return was noted in the access needle and the floppy tip wire was passed into the needle, at which time the skin bunched up and the inserter noted feeling resistance.At this time, the procedure was stopped and the needle and wire were attempted to be removed together; however, the wire was stuck.The needle was removed, the wire was secured with gauze over the site with tegaderm, and the excess wire was coiled and taped to the tegaderm.The patient did not have bleeding at the site; no hematoma and vitals were stable.The patient is currently ventilated.Another physician was consulted, who ordered an xray, and another physician attempted to remove the wire, but was unsuccessful.The guidewire was removed two days later, on (b)(6) 2022, at the bedside with local anesthesia with one suture placed.

Manufacturer Narrative

Returned for evaluation was a guidewire.As received, the guidewire was returned unraveled and the tip was knotted.The guidewire component is supplied to angiodynamics by the supplier heraeus medical.Scar004508 and the guidewire sample were sent to the supplier/manufacturer, heraeus medical for sample evaluation/root cause determination and dhr review of supplier lot {9008425274}.As per the scar004508 response from heraeus medical: in conclusion, there is no evidence to confirm that this failure mode is caused by manufacturing deviations or nonconformances related to out-of-specifications.Based on this investigation this event is considered a non-manufacturer-related issue.The root cause is indeterminable.The reviews of the dhr demonstrate compliance and conformance to applicable procedures and specifications.The customer's reported complaint description of guidewire knotted was confirmed.Although the reported complaint description is confirmed, a definitive root cause for the event cannot be determined.A potential root cause for this guidewire tip knotted failure mode is end user technique in advancing guidewire within the vasculature, especially when tip meets resistance.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 that is supplied in bioflo kits contains the following precaution: note: if using hydrophilic guidewire, fill the wire holder (hoop) or bathe the guidewire with sterile normal saline for injection to ensure activation of the hydrophilic coating prior to the procedure.This may need to be repeated during the procedure by gently flushing the catheter with sterile normal saline solution for injection through the supplied flush assembly with the guidewire in place.C.Recommended tip location is at or below the axillary line.Precaution: if guidewire must be withdrawn, remove the needle and guidewire as a single unit.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 MIDLINE
• Type of Device: MIDLINE CATHETER
• 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: 13654588
• MDR Text Key: 286472910
• Report Number: 1317056-2022-00045
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• 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): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 75 KG