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

Catalog Number	H965457130
Medical Device Problem Codes	Knotted (1340); Retraction Problem (1536); Uncoiled (1659)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although no device is expected to be returned for evaluation, the investigation into this event is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)) device not returned.
Event or Problem Description
Received from fda via user medwatch (b)(4): event description: notes from the interventional radiologist: " during picc placement, the wire became knotted within a small collateral vein of the right upper extremity.The interventional radiology technologist obtained for access to the left brachial vein using real-time ultrasound guidance and a micropuncture kit.The needle tip position confirmed with ultrasound.However, upon advancing the wire, the wire reportedly became coiled in the vein and could not be removed.The wire was lodged at its distal tip and the wire was debraided at the access site.At this time, the right groin was prepped and draped.Percutaneous access to the right common femoral vein was obtained with a micropuncture set using ultrasound guidance.An ultrasound image was obtained and archived.Using 0.035 glidewire berenstein catheter, access to the left brachial vein was obtained.A venogram was performed demonstrating the lodged wire to be within a collateral vein emanating from the brachial vein.Access with collateral vein was ultimately obtained with a wire and catheter.Snaring of the wire was attempted but unsuccessful.Therefore, given the inability to snare a wire, an attempt was made to pull from the access site despite the debraided status at the wire at the access point.Micropuncture sheath was advanced over-the-wire and entire system was pulled together and the wire was removed in one piece.No portion of the wire remained after removal." patient was discharged home in stable condition.The patient returned the next day for placement of a mediport catheter rather than picc in order for her to receive chemotherapy.What was the original intended procedure? picc line insertion.
Additional Manufacturer Narrative
A review of the device history records (dhr)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 january 2017 angiodynamics complaint report was reviewed for the xcela pasv picc product family and the failure mode, "guidewire-unraveled." no adverse trend was identified.Although repeated attempts were made to obtain the used device from the reporting hospital, it was not returned.The guidewire is a purchased device for angiodynamics and a supplier corrective action request (scar) was sent to (b)(4), the manufacturer, for a review of their dhr.(b)(4) response indicated that no quality related issues or manufacturing deficiencies at the time of manufacture were noted.Without a sample evaluation, the relationship between the device and the reported event is unable to be determined.The directions for use packaged with the picc device includes the 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 / XCELA PASV
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5570613
• Report Number: 1317056-2016-00052
• Device Sequence Number: 517872
• Product Code: LJS
• UDI-Device Identifier: H965457130
• UDI-Public: H965457130
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2016

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: Radiologic Technologist
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: H965457130
• Device Lot Number: 4923861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2016
• Supplement Report FDA Received Date: 03/20/2017
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 92