MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4 FR SINGLE LUMEN, FULL TRAY WITH MI; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Catalog Number	9617408
Health Effect - Clinical Codes	Swelling (2091); Thrombosis (2100)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rexj0132 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Patient reported that she had a picc line placed in 2013 in the right basilica vein.The patient stated that her right arm was swollen and under ultrasound, it was discovered that the patient had dvt.During the removal of the picc, the patient stated that the line was kinked and coiled and that removal was difficult.The patient was placed on cumidin for the clotting.

• Brand Name: GROSHONG NXT CLEARVUE 4 FR SINGLE LUMEN, FULL TRAY WITH MI
• Common Device Name: PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6157934
• Report Number: 3006260740-2016-00664
• Device Sequence Number: 710178
• Product Code: LJS
• UDI-Device Identifier: 00801741036002
• UDI-Public: (01)00801741036002(17)150430(10)REXJ0132
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/18/2016

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: 04/30/2015
• Device Catalogue Number: 9617408
• Device Lot Number: REXJ0132
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2016
• 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