MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; CATHETER, INTRAVASCULAR, SHORT-TERM

Catalog Number	H965464701
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation into this event is ongoing and additional information will be requested from the reporting hospital regarding device availability and patient condition.As the guidewire is a purchased component for angiodynamics, a supplier corrective action response (scar) will be forwarded to the supplier.A supplemental medwatch will be submitted upon completion of the investigation.(b)(4).
Event or Problem Description
As reported: "midline placement.Register nurse tried to insert sheath over the wire and it would not advance.When trying to remove the wire, wire could not be removed from patient's arm.Patient was sent to have wire removed by a physician.".
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 midline product family and the failure mode "difficult to remove guidewire." no adverse trend was identified.As the guidewire which was the subject of the complaint is a purchased component for angiodynamics, the supplier, heraeus medical was notifed of the event.They were unable to determine a root cause or confirm the failure, as no sample was returned.There was no observation made during their records review that could identify any contributng factors to the reported failure.All inspection results were recorded within specification limts.A potential cause of a difficult to remove guidewire from the vasculature is tortuous patient anatomy.((b)(4)).

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: CATHETER, INTRAVASCULAR, SHORT-TERM
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7324345
• Report Number: 1317056-2018-00022
• Device Sequence Number: 18859447
• Product Code: FOZ
• UDI-Device Identifier: H965464701
• UDI-Public: H965464701
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150407
• 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,Followup
• Report Date (Section B): 03/08/2018

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: Nurse
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: H965464701
• Device Lot Number: 5275971
• 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: 02/05/2018
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 06/11/2018
• 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