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

Model Number	45812
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
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 (b)(4).
Event or Problem Description
A distributor reported an issue with a biostable picc.On day 321 of chemotherapy treatment, it was noted, after flushing, that the picc was leaking from the lumen, around the 4cm mark on the shaft of the picc , which was just at the insertion site.A small "pin prick" like hole was discovered on the device.This device was replaced with another biostable picc so the patient could continue chemo treatment.There was no report of patient harm or adverse event by the end user.It was indicated the reported device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a bioflo picc.As received the catheter contained a small slice/hole between the 3 and 4 cm marks approximately.015" in length.There were other small marks on the catheter in this same area.The catheter tubing was also discolored in the area adjacent to the hole near the 4-5 cm marks.The tubing was sectioned distal to this area around the 5 cm mark and no abnormalities or thin spots were noted.The customer's complaint description of leak near the 4 cm mark is confirmed.A small slice/hole was found in the catheter tubing.No manufacturing non-conformances or out of specification conditions were observed.A definite root cause could not be determined from sample review.Root cause is likely handling damage during care and maintenance of the picc during dressing changes.This is supported by fact that the catheter tubing has a slice type failure mode and the picc was in use with no issues for more than 9 months.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.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 NY 12801
• MDR Report Key: 11261132
• Report Number: 1317056-2021-00019
• Device Sequence Number: 11648881
• 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
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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: 08/31/2021
• Device Model Number: 45812
• Device Catalogue Number: 45812
• Device Lot Number: 5523226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR