MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TIS; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Catalog Number	0600574
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/03/2017
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, as the device remains in the patient.A lot history review (lhr) of huxj0532 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the sales rep that the patient had a hickman catheter placed on (b)(6) 2016.In (b)(6) of 2017, a full segment repair was completed.Two weeks later the facility tried to access the catheter and it was "sluggish" so they ran contrast with a 10 ml syringe using 3 ml of contrast and on the third time fluoro noticed the metal strut had floated down the catheter and exited into the patient, lodging in his pulmonary artery branch.The sales rep stated that the patient is stable and the facility did not try to remove it.The sales rep stated it was the arterial metal strut that broke off.Patient remains asymptomatic.Facility reported that catheter was removed and replaced.

• Brand Name: HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TIS
• 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: 6494818
• Report Number: 3006260740-2017-00421
• Device Sequence Number: 13705533
• Product Code: LJS
• UDI-Device Identifier: 00801741051876
• UDI-Public: (01)00801741051876(17)181031(10)HUXJ0532
• Combination Product (Y/N): N
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2017

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: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 0600574
• Device Lot Number: HUXJ0532
• 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: 04/14/2017
• 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: Hospitalization
• Patient Age: 2 YR