MAUDE Adverse Event Report: ANGIODYNAMICS XCELA POWER INJECTABLE PICC W/ PASV; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number	UNKNOWN
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has yet to be 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).
Event or Problem Description
A distributor reported an end user experienced an issue when using a picc from an xcela pasv 5f kit.The picc had been in use for 28 days prior to the reported event for a stem cell transplant.While drawing blood, white particles were noted in the disposable syringe, coming from both lumens.The catheter was removed.Due to this event, the patient needed a new picc inserted, and the stem cell transplant was delayed.The frequency of the picc use before this event was reported as intermittent for hydration, medications, and potential blood products.The particles noted by staff were not submitted for analysis by the facility.The patient did not experience any adverse effects or harm due to this incident.
Additional Manufacturer Narrative
The reported device has yet to be 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 (1) 5fr dual lumen bioflo picc w/pasv.As received, the picc returned shows the sample was used, fluid present in both extension tubes, what appears to be tape adhesive residue on pasv valve hubs, extension legs and bifurcation.Complaint sample was reviewed before and after cleaning with no white particles found.The customer's reported complaint description is not confirmed for white particles.The device passed functional testing (flow and leak) and no defects could be found.The customer's reported complaint description of white particles found in syringe during blood aspiration was not confirmed.The returned picc device was evaluated and no manufacturing non-conformances were observed; device met od specification and passed fluid flow and leak testing.A root cause/source for the white particles observed could not be determined, however, there is no indication they are related to the manufacturing of the picc device.A ppotential contributing factor could be foreign material contamination inside the syringe and/or patient blood chemistry.There was no reported lot number for picc upn from the end user customer.The received plexxus product complaint form states device in question was "bioflo picc (5fr)".A ship history report for the customer account number (b)(4) shows that they have only purchased xcela power injectable picc devices, therefore, the bioflo picc must have been inserted at another (unknown) facility.Good faith effort requests for upn and lot number information were made but no response received.The device in question is a 5f dual lumen bioflo picc but upn and ship history for potential lot numbers cannot be performed.The received complaint sample matches this description.Labeling review: the dfu that is supplied in bioflo kits contains the following precaution: it is recommended that only luer lock accessories be used with the · bioflo¿ picc with endexo¿ and pasv¿ valve technology.Repeated over-tightening may reduce hub connector life.Do not use hemostats to secure or remove devices with luer lock hub connections.Flushing - recommended procedure.1.Flush the catheter after every use, or at least every seven days when not in use, to maintain patency.Use a 10 ml syringe or larger.2.Flush the catheter with a minimum of 10 ml of sterile normal saline, using a "pulse" or "stop/start" technique.Warning: if using bacteriostatic saline, do not exceed 30 ml in a 24-hour period.3.Disconnect the syringe and attach a sterile end cap to each luer lock hub.Note: this is the recommended flush procedure for this catheter.If using a different procedure than listed above, the use of heparin may be necessary.Follow institutional protocol for catheter flushing.Precaution: incompatible drug delivery within the same lumen may cause precipitation.Ensure that the catheter lumen is flushed following each infusion.Precaution: if resistance is met when flushing, it is recommended that no further attempts be made.Further flushing may result in catheter rupture.Refer to institutional protocol for clearing occluded catheters.Precaution: place a cap on the hub after use to reduce the risk of contamination.Note: this is the recommended flush procedure for this catheter.If using a different procedure than listed above, the use of heparin may be necessary.Follow institutional protocol for catheter flushing.Precaution: incompatible drug delivery within the same lumen may cause precipitation.Ensure that the catheter lumen is flushed following each infusion.Precaution: if resistance is met when flushing, it is recommended that no further attempts be made.Further flushing may result in catheter rupture.Refer to institutional protocol for clearing occluded catheters.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: XCELA POWER INJECTABLE PICC W/ PASV
• 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
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 16895771
• Report Number: 1317056-2023-00060
• Device Sequence Number: 5956580
• Product Code: LJS
• UDI-Device Identifier: H96560M7015321
• UDI-Public: H96560M7015321
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2023

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 05/09/2023; 07/12/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 05/09/2023; 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown