MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; PORT & CATHETER, IMPLANTED

Catalog Number	H965440250
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device from the reported event has been returned to angiodynamics, however the device evaluation has not yet been conducted.Upon conclusion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported, the physician had placed the port into the patient and closed the pocket.When the port was flushed, the catheter detached and migrated to the right atrium.The catheter was snared and removed without difficulty.The port was then replaced, at that time.
Additional Manufacturer Narrative
In lieu of a reported lot number, a ship history report (shr) was generated for item number h965440250 in order to determine the last three lots shipped to the reporting hospital in the six months prior to the procedure date.The device history records for the lots obtained through the shr (packaging lots) were reviewed for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.Returned for evaluation was one port with catheter tubing attached.As received, the catheter was cut at the 38cm mark.The port /valve assembly contained tool marks all the way around the assembly.As a functional check, the port was clamped off and pressurized with air; no leak was detected, no disconnection occurred.The following dimensions were taken and found to be within specification: catheter tip id, male stem od, port lock id.The reported complaint description of "catheter disconnect: could not be confirmed.No manufacturing non-conformances or out of specification conditions were observed during sample evaluation.Dhr review of the packaging and component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.A possible root cause for the complaint may be that the end user used hemostats to secure the collar to the port and over-tightened the connection.The connector was returned with tool marks on both sides of the connector.The catheter and connector are provided as a separate components within the port assembly kit.The end user attaches the catheter tubing to the port (and secures junction with collar) during the implantation procedure.The directions for use packaged with the device include guidance on proper assembly of the catheter and port, as well as catheter placement.(b)(4).

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7060581
• Report Number: 1317056-2017-00100
• Device Sequence Number: 16493619
• Product Code: LJT
• UDI-Device Identifier: H965440250
• UDI-Public: H965440250
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K131694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2017

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 Catalogue Number: H965440250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 12/21/2017
• 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