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

Catalog Number	H965750335
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although it has been indicated that the guidewire will be returned, it has not yet arrived.As this is a purchased device, angiodynamics will forward the sample to (b)(4) medical for evaluation and completion of a supplier corrective action request (scar).A supplemental medwatch will be submitted upon completion of the investigation.(b)(4).
Event or Problem Description
As reported, during placement of a picc, the guidewire "snapped" while in the patient." there was no trauma to the patient, and the wire was successfully removed.It has been indicated that the used device will be returned to angiodyanamics for evaluation.
Additional 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 bioflo picc product family and the failure mode "guidewire fractured/migrated." no adverse trend was indicated.As the guidewire is a purchased device for angiodynamics, the supplier, heraeus medical, has been made aware of this event for informational purposes.No sample was returned for evaluation, therefore the root cause of the damage to the guidewire was unable to be determined.The directions for use packaged with the bioflo picc provide guidance on insertion and removal of the guidewire including the precaution: "if guidewire must be withdrawn, remove the needle and guidewire as a single unit," to avoid damage.(b)(4).

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7591588
• Report Number: 1317056-2018-00106
• Device Sequence Number: 16567676
• Product Code: LJS
• UDI-Device Identifier: H965750335
• UDI-Public: H965750335
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K131038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: H965750335
• Device Lot Number: 5306734
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 09/10/2018
• 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
• Patient Age: 50 YR