MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / VAXCEL PASV; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number	M001455980
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although the used guidewire was not returned for evaluation, photographs were provided.Angiodynamics has notified our guidewire supplier, (b)(4), of this event via a supplier corrective action request (scar).At the conclusion of the investigation, a supplemental medwatch will be submitted.(b)(4).Device being retained by hospital.
Event or Problem Description
As reported by end user hospital: "picc line insertion attempted in the right basilic insertion site.Needle placed and verified dark color with no pulsation.Guidewire started and met resistance so the nurse stopped immediately.Started to remove the guidewire, as it was being removed the wire started shredding.Pressure was held at insertion site - removed needle and part of the guidewire stayed in the right arm." the patient was then sent to surgery for successful removal of the guidewire fragment.Per end user, patient experienced "prolonged hospital stay." the used device will not be returned, as it is being retained by risk management, however photographs were provided.
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated 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.The angiodynamics (b)(6) 2016 angiodynamics complaint report was reviewed for the vaxcel pasv picc product family and the failure mode "guidewire fractured." no adverse trend was identified.The guidewire sample was not returned, however photographs were provided.The photos, as well as a supplier corrective action request (scar) were forwarded to angiodynamics' guidewire supplier, lake region medical.Their response indicated that without a sample, an exact root cause of the event was unable to be determined.The original event description, however, referenced that the guidewire was pulled back against the needle, which is cautioned against in the directions for use (dfu) provided with the device.The most likely root cause, therefore is related to user technique/operational context.Lake region's manufacturing records for the device lot did not indicate any quality or manufacturing discrepancies.The dfu provided with the picc device states, " precaution: if guidewire must be withdrawn, remove the needle and guidewire as a single unit." (b)(4).Device not returned to manufacturer.

• Brand Name: ANGIODYNAMICS / VAXCEL PASV
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5617339
• Report Number: 1317056-2016-00061
• Device Sequence Number: 18838859
• Product Code: LJS
• UDI-Device Identifier: M001455980
• UDI-Public: M001455980
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K021704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2016

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: M001455980
• Device Lot Number: 4955990
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2016
• Supplement Report FDA Received Date: 01/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR