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

Catalog Number H965458320

Device Problem Difficult to Remove (1528)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/03/2018

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 recent angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "guidewire difficult removal." no adverse trend was identified.As the used guidewire was not returned, a device evaluation was not possible.An x-ray image was provided showing a guidewire looped within the patient vasculature.Tortuous patient anatomy and/or clinical technique could have contributed to this condition, however the root cause of the reported event was unable to be determined.The supplier of the guidewire, lake region manufacturing, has been notified of this event via a scar (supplier corrective action request) for informational purposes.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 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solution for injection through the supplied flush assembly with the guidewire in place.Precaution: if guidewire must be withdrawn, remove the needle and guidewire as a single unit.Do not advance a guidewire past the level of the axilla without the use of real-time imaging guidance.Using guidewire" (b)(4).

Event Description

As reported by angiodynamics' distributor in the (b)(4): "bedside placement of double lumen 5 french picc in side room of haematology ward.Land mark measuring technique with radiological tip verification.Needle placed in left basilic vein under ultrasound guidance on first attempt, this was a large straight vein at depth approximately 2-3 cm.On ultrasound the needle tip was easy to see and placed centrally in the vein with good venous return.Guidewire advance slowly in 2-3 cm increments to approximately 20 cm when it met some resistance and was pulled back, the guidewire continued to move freely within vein.Micro-introducer passed easily first attempt, guidewire still moving freely in vein.Attempted removal of guidewire through micro-introducer unsuccessful due to resistance.Removal of guidewire with introducer attempted but unsuccessful.Removal of guidewire with microintroducer and peelaway sheath attempted but unsuccessful.At this point the guidewire could still be moved within the vein however on gently pulling back to assess the internal length it became stuck, there was approximately 60 cm length externally.A consultant interventional radiologist attempted to remove the stuck wire,however was unable to advance an introducer over the guidewire.Next followed a surgical review and x-ray of humerus which showed the guidewire to be looped back in the vein.The initial plan was to surgically remove the guidewire in theatre with local anaesthetic, however the patient was later transferred to another hospital with a specialist vascular team and the guidewire was removed by pulling with intravenous morphine.The picc insertion nurse specialists placing the picc has 10 years insertion experience." "patient was unharmed - patient due to commence chemotherapy that day of (b)(6) 2018.Radiological examination of left humerus, surgical review with minimal intervention.Delay starting chemotherapy as this has been deferred to the (b)(6) 2018.This was an immune-compromised patient at higher risk of infection and with potential loss of the affected vein.This event was stressful for both patient and staff performing the procedure''.The hospital was unable to return the guidewire, however, did provide an annotated radiological image.

• 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
• MDR Report Key: 7769158
• MDR Text Key: 116638079
• Report Number: 1317056-2018-00156
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: H965458320
• Device Lot Number: 5286923
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2018
• 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): Hospitalization; Required Intervention