MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO PICC WITH ENDEXO TECHNOLOGY; BIOSTABLE PICC

Model Number	45887
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An angiodynamics territory manager reported an issue with a bio-stable 5f dl-55cm ir-145 kit.During the placement procedure, the end user experienced difficulty retracting the guidewire and had to apply force.This resulted in the tip of the guidewire detaching, approximately 8cm, into one of the lumens.This was discovered via x-ray.As a result of this incident, the device was removed from the patient and another picc was placed.The patient did not experience any adverse effects or harm as a result of this incident.
Additional Manufacturer Narrative
The reported 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).
Additional Manufacturer Narrative
Returned for evaluation was one piece of guidewire.As received, the customer only returned the floppy tip of the guidewire.Scar004511 and the sample were sent to the supplier,(b)(4) for sample evaluation/root cause determination and dhr review of supplier lot {9008140389}.As per the scar004511 results, supplier heraeus medical, the sample has broken in the distal end, however, there are enough visual controls in place to detect similar issues during the manufacturing process, according to procedure.The sample was measured in the welding dome with a calibrated ring gauge eq-0108-091 and it is in conformance and compliance with the respective procedures.Additionally, this product is 100% inspected during the manufacturing process with calibrated ring gages that allows a high detectability in the process of od nonconformances.In conclusion, there is no evidence to confirm this event was caused by manufacturing deviations nor nonconformances related to out-of-specification or procedures not followed.Based on this investigation there are no reasons to think this event is a manufacturer-related issue.The customer's complaint description is confirmed for guidewire tip detached.Although the reported event description is confirmed, a defintive root cause for the tip detach cannot be established.A potential root cause for this type of failure mode is end user pulling guidewire back against needle during access and then pull to failure during removal from picc after catheter tip placement.It was reported that end user "had to apply force" when retracting guidewire from catheter.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: direction for use is provided with this picc device and includes the following statements: precautions if guidewire must be withdrawn, remove the needle and guidewire as a single unit.Catheter preparation note: for dual lumen catheters, be sure to prime each lumen prior to insertion.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 TECHNOLOGY
• Common Device Name: BIOSTABLE PICC
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 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 ; 5086587805
• MDR Report Key: 13659532
• Report Number: 1317056-2022-00055
• Device Sequence Number: 5009447
• Product Code: LJS
• UDI-Device Identifier: H965458870
• UDI-Public: H965458870
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K131038
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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: 09/30/2023
• Device Model Number: 45887
• Device Catalogue Number: 45887
• Device Lot Number: 5702942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• 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
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 127 KG