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

Catalog Number	H96560M0721311
Medical Device Problem Code	Uncoiled (1659)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used guidewire was returned to angiodynamics.As this is a purchased component, it has been forwarded to the supplier, heraeus medical, with a supplier corrective action request (scar).Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
After placing a midline catheter in the patient's left arm, the complaint reporter "went to remove the guidewire with the inner part of the dilator and they were both coming out and at the very end.The guidewire was floppy." it appeared to have uncoiled.The used device has been returned to angiodynamics for evaluation.
Additional Manufacturer Narrative
A review of the device history records (dhr) was performed for the indicated packaging and picc assembly 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 unraveled." no adverse trend was identified.As the guidewire is a purchased component for angiodynamics, the returned sample was forwarded, along with a scar (supplier corrective action request) to lake region medical components, the manufacturer.Their visual observation found that : the guidewire was unraveled beginning at the proximal weld and extending approximately 33cm distal of the proximal joint.A kink was also present in the core wire.The returned guidewire was incomplete in that the distal weld was not present on the returned guidewire and the ball weld was not present on the returned core.Lake region's conclusion was that based on the evidence presented by the sample and the information provided by the supporting documentation, improper use, improper handling, excessive force, and/or improper removal from packaging appear to have impacted on the event as reported.Lake region medical also performed a dhr review of the reported lot and found no indication of a manufacturing defect that could have impacted the reported event.(b)(4).

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: CATHETER, INTRAVASCULAR, LONG-TERM
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7237369
• Report Number: 1317056-2018-00007
• Device Sequence Number: 16401969
• Product Code: LJS
• UDI-Device Identifier: H96560M0721311
• UDI-Public: H96560M0721311
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K163452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2018

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
• Operator of Device: Physician
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: H96560M0721311
• Device Lot Number: 5235439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR