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

Catalog Number	H965458120
Medical Device Problem Codes	Kinked (1339); Difficult to Remove (1528)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although it has been indicated that the device from the reported incident has been discarded at the hospital, the investigation into this event is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).Device discarded at hospital.
Event or Problem Description
As reported by angiodynamics' distributor in the (b)(6): "during a picc placement procedure a needle was placed in the right cephalic vein under ultrasound guidance.Guidewire advanced, then met obstruction.Removal of needle and guidewire attempted.Needle removed, guidewire remained stuck and could not be removed by pulling.Patient referred to anesthetic and on-call surgical teams who attempted removal by manipulation.Radiological examination showed flexible tip of guidewire kinked in vein.Guidewire removed under local anesthetic in theatre by cut-down into vein and ligation." all used devices were discarded at the hospital.
Additional 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 recent angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "guidewire difficulty removing/withdrawing." no adverse trend was identified.In addition, this is the only reported complaint for this failure mode in the past 15 months for the bioflo picc product family.As the used guidewire was not returned, a device evaluation was not possible and the root cause of the reported event was unable to be determined.The directions for use packaged with the picc device include the following precautions and guidance: "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: insert introducer needle, bevel up, into selected vein, and confirm vessel entry.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).Device not returned to manufacturer.

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6605873
• Report Number: 1317056-2017-00040
• Device Sequence Number: 16436610
• Product Code: LJS
• UDI-Device Identifier: H965458120
• UDI-Public: H965458120
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: H965458120
• Device Lot Number: 5119068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 06/16/2017
• 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