MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC HF CATHETER 5F MAXIMAL BARRIER TRAY (TRIPLE-LUMEN); PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	3385108QD
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/03/2015
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 rezi0259 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On (b)(6) 2016 per sales representative, facility contact reported that they found a piece of the micro introducer wire still in the patient.This was noticed when the patient was admitted.A small piece of the wire was noticed in the patient's chest x-ray, since picc was placed.The wire migrated to the patient's heart and the patient was sent to ir for retrieval but wire could not be retrieved.

• Brand Name: POWERPICC HF CATHETER 5F MAXIMAL BARRIER TRAY (TRIPLE-LUMEN)
• 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: 5855219
• Report Number: 3006260740-2016-00402
• Device Sequence Number: 1603950
• Product Code: LJS
• UDI-Device Identifier: 00801741028175
• UDI-Public: (01)00801741028175(17)170328(10)REZI0259
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2016

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: 03/28/2017
• Device Catalogue Number: 3385108QD
• Device Lot Number: REZI0259
• 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: 08/08/2016
• 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