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

Catalog Number	H965458320
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	02/25/2016
Type of Reportable Event	Serious Injury
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 (b)(4) 2016 angiodynamics complaint report was reviewed for the bioflo pasv picc product family for the failure modes "hub broken/cracked," and "patient injury - dvt." no adverse trends were indicated.As received, only the purple valve with oversleeve was returned for evaluation.An injection cap (needleless connector) was attached to the hub.The female luer lock component of the purple valve on the picc was confirmed to be cracked just adjacent to the molded parting line.The most likely root cause for the crack along the valve parting line is an over-tightened connection with a mating male luer (likely the needleless connector).The directions for use (dfu) supplied with the reported picc device contain caution that "repeated over-tightening may reduce hub connector life," and not to use hemostats to "secure or remove devices with luer lock hub connections." a definitive root cause for the dvt issue could not be determined based on the sample evaluation.Potential contributing factors that may affect dvt include the following: high risk patient population, e.G.Oncology.Use of cephalic vein for picc placement, i.E.Large fr catheter in smaller vessel.Picc placement techniques, i.E.Excessive catheter manipulation that can damage the vessel wall.(b)(4).
Event or Problem Description
As reported by angiodynamics' distributor in the (b)(6): indwelling picc was removed and replaced due to a cracked hub.The patient also reported having swelling in the left arm which had the picc in situ with pitting odema with an upper circumference of 45cm compared to the right arm which measured 33cm.Doppler on the left arm diagnosed a thrombosis which is being treated with antithrombolytics.The patient did not have risk factors for thrombosis, neither is he receiving chemotherapy.Patient has a port-cath in situ which is functioning well.Per complaint reporter, "thrombosis is one of the side effects we discuss with patients when consenting for piccs." it is not implied that the crack in the hub of the picc was the cause of the thrombosis.

• 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: 5529402
• Report Number: 1317056-2016-00045
• Device Sequence Number: 820662
• Product Code: LJS
• UDI-Device Identifier: H965458320
• UDI-Public: H965458320
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/29/2016

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: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: H965458320
• Device Lot Number: 4928441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2016
• Initial Report FDA Received Date: 03/28/2016
• 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