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

Model Number	45889
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference pr25555.
Event or Problem Description
A distributor reported an issue with a biostable picc w/pasv.The picc was inserted and the tip location was confirmed to be in the svc/ra junction, via x-ray.No issues were noted during insertion.The picc was being used for iv antibiotics.A few weeks later, the device would not aspirate; therefore, another x-ray was ordered.The imaging showed that the picc had "looped at 7cm from the distal tip with kink." the picc was removed and a visual inspection showed that the picc was noticeably kinked on removal.There was no indication the picc was replaced.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.It was indicated the reported device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description cannot be confirmed based on the nature of the kinking/knotting in the body and no sample was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Potential contributing factors for this complaint may be catheter positioning techniques used during the placement procedure or patient anatomy.A review of the device history records was performed for the reported 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.Labeling review: the directions for use (dfu) that is provided in the bioflo picc kits contains the following directions and precautions: if catheter and accessories show any sign of damage (crimped, crushed, cut, etc.), do not use.Do not fully insert catheter up to suture wing.Avoid sharp or acute angles during insertion which may compromise catheter functionality.Following institutional policy, secure catheter externally to prevent catheter movement, migration, damage, kinking or occlusion.Do not place the catheter into the right atrium or the right ventricle of the heart.Avoid sharp or acute angles during insertion which may compromise catheter functionality.If placing catheter at patient bedside turn patient's head toward insertion side with chin to shoulder.15.Slowly and incrementally, insert catheter assembly through the peelable sheath to desired tip location.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).
Additional Manufacturer Narrative
Returned for evaluation was one bioflo picc with pasv.As received, the bioflo picc contained bio material {clear fluid} in the extension tubing.The valve was visualized microscopically.The valve disc was confirmed to be slit and centered.There were no other kinks, compressions or other damage noted to the catheter.There were no molding/manufacturing related non-conformances noted to the returned sample.During the cleaning process a 10ml syringe was used to infuse the cleaning solution through the valve and through the catheter.Infusion/aspiration was performed with no difficulties.Also, a.018 inspection guidewire (mandrel wire with no floppy tip) was used to verify lumen patency.The 0.018 guidewire was inserted through the catheter with no difficulty.The customer's complaint of picc catheter looped inside patient was confirmed via x-ray image provided, however, no kink/damage to catheter tubing was confirmed via evaluation of returned complaint sample.Infusion and aspiration pressures were measured on the pasv valve and met specification.No manufacturing non-conformances were observed during sample evaluation and the catheter tubing met dimensional specifications.The root cause for infusion and/or aspiration difficulty was likely duet to catheter tubing looping inside of the patient, however, no manufacturing non-conformance of the catheter tubing was observed.Picc care and maintenance and patient anatomy are likely contributing factors to the catheter tubing looping in situ.A review of the device history records was performed for the reported 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.Labeling review: the directions for use (dfu) that is provided in the bioflo picc kits contains the following directions and precautions: if catheter and accessories show any sign of damage (crimped, crushed, cut, etc.), do not use.Do not fully insert catheter up to suture wing.Avoid sharp or acute angles during insertion which may compromise catheter functionality.Following institutional policy, secure catheter externally to prevent catheter movement, migration, damage, kinking or occlusion.Do not place the catheter into the right atrium or the right ventricle of the heart.Avoid sharp or acute angles during insertion which may compromise catheter functionality.If placing catheter at patient bedside turn patient's head toward insertion side with chin to shoulder.15.Slowly and incrementally, insert catheter assembly through the peelable sheath to desired tip location.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).
Event or Problem Description
Additional information provided reported the defective picc was not replaced.
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 investigation will be sent via a follow up medwatch.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 NY 12801
• MDR Report Key: 10927478
• Report Number: 1317056-2020-00190
• Device Sequence Number: 716151
• Product Code: LJS
• UDI-Device Identifier: H965458890
• UDI-Public: H965458890
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 45889
• Device Catalogue Number: 45889
• Device Lot Number: 5591621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 11/11/2020; 11/11/2020; 11/11/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/27/2020; 01/17/2021; 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR