MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO MIDLINE; MIDLINE CATHETER,,

Catalog Number	46490
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
An ir director reported an issue with a bioflo midline 5f dl-20cm max sterile barrier drape kit w/ two nitinol guidewires.During the placement procedure, the guidewire got stuck in the patient's vessel.Two different ir physician's attempted to remove the guidewire and were unsuccessful.At the time of notification, the patient was currently scheduled to go to surgery to get the guidewire removed from the vessel.Additional information reported the patient underwent vascular surgery at which time they were able to successfully remove the guidewire.When they did the vascular removal, the physician used the same insertion site on the right side of the arm as the ir physician and the gw was right there in the vessel of the arm and was retrieved.The x-ray shows the entire length of the gw goes from the insertion site all the way to the heart.It's a long wire.The midline catheter itself was never inserted.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.There was no report of permanent patient harm or injury.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description cannot be confirmed as no sample was returned.Without receiving a sample for evaluation a root cause for this event cannot be determined.The guidewire component is supplied to angiodynamics by the supplier heraeus medical components.Scar004291 was sent to the supplier, heraeus medical components for dhr review of supplier lot.As per supplier heraeus medical's investigation, all inspections results were recorded within specification limits.The product specifications were met with no non-conformities reported for manufacturing and inspection.General training review was performed.It was verified that all personnel were properly trained in all manufacturing process steps and quality inspections as well.A potential root cause for this type of failure mode is clinician pulling the guidewire back against the needle.Several attempts were made to get more information regarding this event but customer refused to provide information citing hippa and legal reasons.A review of the angiodynamics' device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: the dfu that is supplied in dfu, 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
• Common Device Name: MIDLINE CATHETER,,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• MDR Report Key: 11621951
• Report Number: 1317056-2021-00073
• Device Sequence Number: 19807806
• Product Code: FOZ
• UDI-Device Identifier: H965464901
• UDI-Public: H965464901
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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: 09/30/2021
• Device Catalogue Number: 46490
• Device Lot Number: 5634755
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other