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

Catalog Number	H965750335
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although upn and scope of lots used by reporter is known, no dhr or ship history review is required: it is unconfirmed whether angiodynamics product was involved in the reported event or which guidewire in the packaged upn was used.Similar complaint trend review: the reporting facility did not indicate the affected {guidewire} product used in the reported event.As a result, a search for similar complaints of the same lot/batch number could not be performed.The recent angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "guidewire fractured." no adverse trend was indicated.The directions for use packaged with the bioflo picc device contains guidance on proper guidewire insertion and removal including the precaution, " if guidewire must be withdrawn, remove the needle and guidewire as a single unit." the reported complaint is unable to be confirmed, nor has it been confirmed that the event involved angiodynamics product.(b)(4).
Event or Problem Description
The line company, a mobile picc team reported that they got a call from one of their customers stating that piece of guidewire (used to place a picc) may have broken off into a patient's body.Notification that they received read, "(b)(6) 2018 xray linear radiodensity overlying the pulmonary artery.On (b)(6) 2018 xray notes 2 cm broken wire foreign body in the pulmonary artery unchanged from (b)(6)." the family of the patient did not wish to have the guidewire fragment removed.The mobile picc group was notified on 7/26/2018.They understand that the patient involved also had a picc line (manufacturer unknown) placed at another hospital.They are notifying all manufacturers whose piccs were used on this patient.The line company placed 5 bioflo piccs (from 3 different product lots) in the time frame between (b)(6) and (b)(6) 2018.

• Brand Name: ANGIODYNANAMICS / BIOFLO
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7808942
• Report Number: 1317056-2018-00161
• Device Sequence Number: 13836765
• Product Code: LJS
• UDI-Device Identifier: H965750335
• UDI-Public: H965750335
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K131038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/23/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: H965750335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/23/2018
• 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