MAUDE Adverse Event Report: BIOFLO MIDLINE; MIDLINE CATHETER

Catalog Number 46490

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

The reported 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

A nurse reported an issue with a bioflo midline 5f dl-20cm max sterile barrier drape kit w/ two nitinol guidewires.During a procedure, there were issues with the guidewire and part of the wire was discovered to be left in the patient.This occurred when the doctor exchanged a picc with the midline catheter.The guidewire frayed/unraveled/stretched and part of it broke off.This was noticed when the doctor regained access at another site and it showed up on the x-ray.It was reported there was no resistance while trying to remove it.A new guidewire was used to complete the procedure.It was reported that the physician opted to leave the fragments in the patient as it was believed the patient would expel the fragment; however, the patient will be observed and has not experienced any adverse effects or harm as a result of this incident.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.

Manufacturer Narrative

Returned for evaluation was one guidewire in two pieces.The returned guidewire was in two pieces and appeared unraveled and bent in different location.The customer's reported complaint description of guidewire fractured was confirmed.The guidewire component is supplied to angiodynamics by the supplier heraeus medical components.Scar004336 and the sample were sent to the supplier, heraeus medical components for a device history records (dhr) review of supplier lots and root cause/corrective action.As per supplier heraeus medical scar response, the most probably root cause was the tip of the guidewire became entrapped in some manner during the field process.Probably substantial force was applied to the guidewire to free the guidewire tip resulting in the separation of the distal tip and the broke, therefore it is considered a non-manufacturer related issue.The reviews of the dhr demonstrate compliance and conformance to applicable procedures and specifications.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 midline catheter kits contains the following precaution: precautions: do not advance or withdraw a guidewire against resistance until the cause of the resistance has been determined.Excessive force against resistance may result in guidewire damage or vessel perforation.Caution: the guidewire should not be withdrawn through the introducer needle.If the guidewire must be withdrawn while still inside the needle, simultaneously remove both the needle and the wire as a unit to prevent the needle from damaging the guidewire.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
• MDR Report Key: 11900215
• MDR Text Key: 253169746
• Report Number: 1317056-2021-00104
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: H965464901
• UDI-Public: H965464901
• Combination Product (y/n): N
• PMA/PMN Number: K161866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 46490
• Device Lot Number: 5667007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Date Manufacturer Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2021
• 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): Other