MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 7 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	7711700
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/26/2016
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 22lka578 showed no other similar product complaint(s) from these lot numbers.Sample remains in patient.
Event or Problem Description
It was reported that the patient was hospitalized for the removal of catheter which was broken and had disintegrated.Removal was by puncture under echo control via the right femoral and the capture of the catheter tip was at the right auricle.The removal was reportedly impossible due to a total calcification of the catheter.The removal attempt failed and the doctor decided to stop the procedure because there was no risk of migration.The patient returned to his home and remains under medical supervision.The catheter was placed in the patient 14 years ago.

• Brand Name: GROSHONG 7 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUF
• 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: 5457515
• Report Number: 3006260740-2016-00055
• Device Sequence Number: 16218781
• Product Code: LJS
• UDI-Device Identifier: 00801741036736
• UDI-Public: (01)00801741036736(17)051231(10)22LKA578
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 02/01/2016

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: 12/31/2005
• Device Catalogue Number: 7711700
• Device Lot Number: 22LKA578
• 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: 02/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR