MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number	60M701102
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
An end user reported an issue with a can 5f dl bioflo pasv nursing tray ((b)(6) hospital (stp) kit.The picc placement procedure was started.The patient's right basilic vein was accessed approximately 8-10cm above the ac without difficulty.No challenges with vascular anatomy were noted on assessment.No visible damage to the guidewire was noted prior to insertion.Ultrasound was used to assist with picc insertion.The guidewire threaded through needle without difficulty.Once resistance was felt, advancement of the wire was halted, and removal of the guidewire was attempted.The access needle was removed with no issues.The guidewire was emoved until approximately the last 2/3cm.An ultrasound of arm was performed, verifying that the wire was not in the vein.A larger dermatotomy was made with a scalpel to assist with removing the wire.The wire started to stretch, with the potential to sheer at that point, so further removal attempts were halted and referral to ir was made.The site was covered with a large transparent occlusive dressing to secure everything in place.Impact of incident: the wire could not be removed, and therefore the patient required interventional radiology for wire removal.Additional information provided post reporting: new picc insertion not done.A piece of guidewire remains in patients arm ir unsuccessful - surgical consult done to assess whether device can be retrieved or left.Unfortunately, no other information is available at this time.08/15/2023 additional information: it is unknown if the fragment was removed.They were unable to remove it under ir so a surgical consult was done and at that time the reporter was no longer able to access the patients' chart as patient was the referred to a different team.
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.Reference: (b)(4).
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of the guidewire tip detached cannot be confirmed since no complaint sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.The guidewire accessory device is supplied to angiodynamics by the manufacturer heraeus medical.Scar004819 was sent to heraeus medical to make them aware of this reported occurrence and for dhr review of the reported lot.Dhr review of the packaging/accessory lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Labeling review: dfu item number which is supplied to the end user with this catalog number states: precautions: refer to procedural steps for additional precautions.Do not advance a guidewire past the level of the axilla without the use of real-time imaging guidance.Never use force to remove the stylet.Resistance can damage the catheter.If resistance or bunching of the catheter is observed, stop stylet withdrawal and allow the catheter to return to normal shape.Withdraw both the catheter and stylet together approximately 2 cm and reattempt stylet removal.Repeat this procedure until the stylet is easily removed.Once the stylet is out, advance the catheter into desired position (zero mark).Precaution: if guidewire must be withdrawn, remove the needle and guidewire as a single unit.Gently withdraw needle from guidewire while holding guidewire in place.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 PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY
• Common Device Name: 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 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 17644365
• Report Number: 1317056-2023-00109
• Device Sequence Number: 20847920
• Product Code: LJS
• UDI-Device Identifier: H96560M7011021
• UDI-Public: H96560M7011021
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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: 08/31/2024
• Device Catalogue Number: 60M701102
• Device Lot Number: 5752807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown