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

Catalog Number	H965460120
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Additional 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 device evaluation will be sent via a follow up medwatch.Complaint # (b)(4).
Event or Problem Description
As reported: guidewire became stuck in vessel and could not be removed.Also stuck at the end of sheath dilator.Not reported to (b)(6) (by account) as it is suspected as user error.The guidewire tip has split possibly caused by being sheared by the needle.Guidewire was removed by ir.New line was sited.No serious patient injury or complications were reported.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a 4f dilator sheath with the guidewire still advanced inside of it.As received, the guidewire was stuck inside the 4f introducer and was contaminated with bio hazard material {dried blood} inside and out.The tip of the dilator was damaged/bent, and the guidewire appeared split.The sample was soaked in the cleaning solution.After the sample soaked, the guidewire was unable to be removed.The reported complaint is confirmed for wire stuck in introducer.The guidewire was unable to be removed from the dilator and was not fractured but split (still in one piece).A definitive root cause could not be determined due to the condition of the returned samples.A possible root cause may be the guidewire was pulled back against the needle which is cautioned against in the dfu.The dfu contains the following statements, the guidewire should not be withdrawn through the introducer needle.If the guidewire must be withdrawn while still inside the needle, simultaneously remove both the needle and the wire as a unit to prevent the needle from damaging the guidewire.A device history review of the packaging and purchased component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.As this is considered an isolated incident, no corrective action is required.The directions for use, provided with this product, states: 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 trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

• Brand Name: BIOFLO MIDLINE
• Common Device Name: MIDLINE CATHETER,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8932204
• Report Number: 1317056-2019-00114
• Device Sequence Number: 291011
• Product Code: FOZ
• UDI-Device Identifier: H965460120
• UDI-Public: H965460120
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2019

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: 03/31/2021
• Device Catalogue Number: H965460120
• Device Lot Number: 5459423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 09/27/2019
• 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: Required Intervention