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

Catalog Number H74960M0335611

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problem Ischemia (1942)

Event Date 02/06/2017

Event Type  Injury  

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 recent angiodynamics complaint report was reviewed for the xcela picc product family and the failure mode "malposition." no adverse trend was indicated.Labeling review: it cannot be determined if the picc was used in accordance with its labeling (dfu) since the sample was not returned for evaluation.As noted during the review of the dfu (directions for use) item number 146000579-01 that is supplied in the reported device, the following precautions/warnings are stated: "if catheter and accessories show any sign of damage (crimped, crushed, cut, etc.), do not use.Do not fully insert catheter up to suture wing.Avoid sharp or acute angles during insertion which may compromise catheter functionality.Following institutional policy, secure catheter externally to prevent catheter movement, migration, damage, kinking or occlusion." from the information provided by the end user, it is likely that malpositioning of the catheter resulted in the reported event.(b)(4).Device not returned to manufacturer.

Event Description

Information as received from end user hospital: " a picc line was placed in patient's right arm several hours later the arm was cold and pulseless.It was determined that the picc was not in an appropriate placement.Surgery was recommended by declined by patient's husband.X-ray taken on (b)(6) 2017 initially confirmed appropriate placement.Venous blood gases taken on (b)(6) 2017 revealed oxygen level of 135 raising suspicion of malplacement of the picc." patient's past medical history included: " hypertension, hyperlipidemia, cva, cad, aaa, pad, prior stemi and chronic alcohol abuse." the catheter is believed to still be implanted in the patient.

• Brand Name: ANGIODYNAMICS / XCELA
• Type of Device: 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: law ryan ; 10 glens falls technical park; glens falls, NY 12801
• MDR Report Key: 6399378
• MDR Text Key: 69802034
• Report Number: 1317056-2017-00027
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: H74960M0335611
• UDI-Public: H74960M0335611
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/13/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: H74960M0335611
• Device Lot Number: 5138454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 63