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

Catalog Number	H96560M7801261
Medical Device Problem Codes	Obstruction of Flow (2423); Malposition of Device (2616)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although no sample is being returned for evaluation, the investigation into this event is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
As reported by hospital in (b)(6): picc placed (b)(6) 2018 - seen for occlusions (b)(6) (tpa).Incidental xray (b)(6) shows good positioning.Hd etoposide given (b)(6).Incidental xray done (b)(6) shows curl.Picc removed and replaced (b)(6).Hospital has stated that the dfu for etoposide lists polyurethane as contraindicated.
Additional Manufacturer Narrative
Correction - initial medwatch, lot # should be unknown, expiration date should be unknown, device manufacture date should be unknown.In lieu of a reported lot number, a ship history report (shr) was generated for item number h96560m7801261 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: (5289472, 5285643 and 5277220).The device history records for the lots obtained through the ship history report (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.The recent angiodynamics complaint report was reviewed for the complaints reported for the bioflo picc product family and the failure mode "aspiration difficulty - removed." no adverse trend was identified.We reviewed our chemical testing associated with the bioflo picc catheter tubing and confirmed that etoposide is not a new drug and it was included in our chemical compatibility evaluation.A drug representing this class of chemotherapy agents was tested.Etoposide is generic drug name but review of one manufacturer's directions for use of their drug cautioned against using the drug undiluted.The undiluted use of the etoposide drug is a potential root cause for the issues experienced with the bioflo picc device.The end user hospital has stated that they are now diluting this drug for treatment.(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: 7540993
• Report Number: 1317056-2018-00088
• Device Sequence Number: 13901772
• Product Code: LJS
• UDI-Device Identifier: H96560M7801261
• UDI-Public: H96560M7801261
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K163452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2018

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: 01/31/2020
• Device Catalogue Number: H96560M7801261
• Device Lot Number: 5304149
• 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: 04/27/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR