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

Catalog Number UNKNOWN

Device Problem Uncoiled (1659)

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

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation into this event is on-going as angiodynamics is attempting to obtain further information regarding the nature of the event and the device(s) involved.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).Device not returned to manufacturer.

Event Description

As reported, patient has a ppn - put catheter in approx.2 weeks ago.Patient was saying it "wasn't working." patient allergic to contrast, so guidewire was inserted to check catheter.When the wire came out there was a "tear in the wire 2cm in length." picc was removed and replaced.No patient injury was reported.

Manufacturer Narrative

The reported complaint description cannot be confirmed as no product was returned for evaluation.Additionally, a device history records review was unable to be conducted as no lot number was provided.The angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode, "guidewire unravelled." no adverse trend was identified.Angiodynamics' process controls related to the bioflo picc are as follows: incoming inspection of tapered extruded tubing: a visual inspection based on an aql, which includes but is not limited to, visualizing for dents in the catheter tubing is performed.Dents you can feel, but cannot see are acceptable; dents you can feel and see are rejectable.In addition, a guidewire insertion test is performed.The guidewire must pass through the entire length of the extrusion with no resistance.Additionally, manufacturing performs an in-process visual inspection for molding defects and a guidewire insertion test to verify lumen patency, at defined intervals throughout the molding process of each work order.The guidewire must pass through the catheter with little to no resistance to be considered acceptable.At this time, angiodynamics has deemed their process controls adequate to address the reported failure mode.(b)(4).Device not returned to manufacturer.

• Brand Name: ANGIODYNAMICS / BIOFLO
• 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: 5570596
• MDR Text Key: 42440617
• Report Number: 1317056-2016-00053
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2016
• Initial Date FDA Received: 04/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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