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

Catalog Number	H965458950
Medical Device Problem Code	Physical Property Issue (3008)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation into this event is ongoing, both at angiodynamics and at (b)(4).Upon completion of the investigation a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
Angiodynamics was notified by (b)(4), the supplier of introducer sheaths, that they have initiated a recall (1649395-05-02-2018-001-r) on specific device lots due to "unsafe levels of bacterial endotoxins (pyrogens) that were introduced during a manufacturing step." (b)(4) has informed angiodynamics that use of the introducers may expose patients/end users to "bacterial endotoxins, also called pyrogenic bacteria that can activate the inflammatory process and produce fever, chills, and hypotension in a patient." as a result of the (b)(4) recall, angiodynamics is conducting a voluntary recall (removal) of the affected angiodynamics products.The recall notification letters were delivered to affected consignees on friday may 11, 2018.After receiving notification, the end user hospital has reported: "patient exhibited potential infectious symptoms the next day.No treatment required.(b)(6) - increased temp one time to 38.6 (101.5) despite antibiotics with c/o chills, sweats, generalized aches and ha patient had now recalled picc line device placed (b)(6) 2018.
Additional Manufacturer Narrative
In lieu of a reported lot number, a ship history report (shr) was generated for item number (h965458950) in order to determine the last three lots shipped to the reporting hospital in the six months prior to the procedure date.The three lots obtained through the shr were (5295311, 5304321 and 5312589).The device history records for the lots obtained through the ship history report (packaging lots) were reviewed.In addition, the corresponding lots for purchased component item number 06509208 (angiodynamics lot 639464 {supplier lot number 17262440}, 640497 {supplier lot number 17356436} and 640330 {supplier lot number 17321977} packaged in it.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 "patient injury - infection." no adverse trends were indicated.The end user hospital's reported complaint description cannot be confirmed given the nature of the adverse event.The customer was reviewing patient's affected by the galt sheath recall and observed infection post placement.Angiodynamics received bio-testing results of galt manufacturing process performed by nelson labs.Only one organism present has potential to produce endotoxin reaction.The relationship between the galt sheath and the patient infection cannot be definitively determined by angiodynamics.(b)(6) has initiated a capa to address the issue regarding recall # z-2196-2018.(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: 7591592
• Report Number: 1317056-2018-00110
• Device Sequence Number: 14002083
• Product Code: LJS
• UDI-Device Identifier: H965458950
• UDI-Public: H965458950
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K133264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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 Catalogue Number: H965458950
• 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: 06/08/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2196-2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Weight: 82