MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number H965458320

Device Problems Crack (1135); Uncoiled (1659)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/22/2017

Event Type  Injury  

Manufacturer Narrative

A review of the device history records was performed for the indicated 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.The (b)(6) 2017 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure modes "guidewire unravelled" and "guidewire fractured." no adverse trends were identified.As no sample was returned, angiodynamics was unable to provide lake region, the guidewire manufacturer with a device for evaluation.The conclusion as to the root cause of the event, however has been determined to be user error: an email received on (b)(6) 2017 from the distributor quotes the end user hospital as stating, "after an internal review, i think we have come to the conclusion that it was a 'user issue' in trying to retract the guidewire with the needle still in situ." the directions for use (dfu) provided with the bioflo picc provide guidance on use of the needle and guidewire which are provided."precautions: exercise care when advancing the catheter or guidewire to avoid trauma to the vessel intima.Do not use clamps, toothed or ribbed forceps.Do not use clamps or other instruments with teeth or sharp edges on the catheter or other instruments to advance or position catheter as catheter damage may occur.Using guidewire: a.Insert introducer needle, bevel up, into selected vein, and confirm vessel entry.B.Insert soft or guiding tip of the guidewire through the needle and into the vein to the desired position based on clinical practice guidelines and standards or institutional policy and procedure.Note: if using 145 cm or 70 cm 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solution for injection through the supplied flush assembly with the guidewire in place.Precaution: if guidewire must be withdrawn, remove the needle and guidewire as a single unit." (b)(4).

Event Description

As reported by angiodynamics' distributor in the (b)(6), during a picc placement, intial access to the vein went without difficulty and there was good blood return.When attempting to remove the guidewire, there was resistance.The needle was then removed, and the guidewire remained stuck.The guidewire uncoiled and then snapped, leaving only 1 inch externally.The guidewire was eventually able to be removed after a cut-down.

• Brand Name: ANGIODYNAMICS / BIOFLO
• Type of Device: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 6861391
• MDR Text Key: 85937829
• Report Number: 1317056-2017-00072
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: H965458320
• UDI-Public: H965458320
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: H965458320
• Device Lot Number: 5114245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2016
• 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