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

Catalog Number M001456760

Device Problem Uncoiled (1659)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

While it has been indicated that the used guidewire will be returned for evaluation, it has not yet been received.As the guidewire is a purchased device for angiodynamics, a supplier corrective action request (scar) will be sent to the manufacturer, along with the sample, once it is received.A supplemental medwatch will be submitted upon completion of the investigation.(b)(4).Device not yet returned to manufacturer.

Event Description

As reported by angiodynamics' distributor in the (b)(6), a guidewire packaged with a picc device "unravelled" during use.There was no report of patient injury.It was indicated that the used guidewire would be returned for evaluation.

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 complaint report was reviewed for the product family, xcela picc and the failure mode, "guidewire unraveled." no adverse trend was identified.The guidewire was returned inside its protective hoop, and was noted to be unraveled.As this is a purchased component for angiodynamics, the device was forwarded to our guidewire supplier, lake region manufacturing, along with a supplier corrective action request (scar).Lake region's evaluation indicated that the sample presented fractures of the coil and core wires; the distal tip joint and all other material distal of the fractures was not included in the sample return.The coil wire fracture presented indications of ductile, tensile overload with torsional loading.The sample presented numerous bends scattered over the length of the device.The bend damage appeared consistent with advancing the wire against resistance; the fractures appear to have occurred during subsequent manipulation.Clinical and/or procedural factors appear to have impacted on the event.Lake region's review of it's device history records indicate that the product met specification prior to shipping.(b)(4).

• Brand Name: XCELA PICC
• 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 ; 5187424488
• MDR Report Key: 5842952
• MDR Text Key: 51113819
• Report Number: 1317056-2016-00112
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K070002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: M001456760
• Device Lot Number: 4931447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2015
• 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