MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (70CM GUIDEWIRE); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Codes	Cardiopulmonary Arrest (1765); Death (1802); Low Blood Pressure/ Hypotension (1914); Reaction (2414)
Date of Event	03/16/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recx0547 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (recx0547) have been reported from the same facility in (b)(6).Device has not yet been returned for evaluation.
Event or Problem Description
It was reported that a few hours after picc insertion the patient died.Facility stated uncomplicated basilic placement in ir suite under fluoroscopy.Facility reported use of more than 5 ml of chg.Picc was inserted at 14:48.Patient was stable after picc insertion.After procedure patient developed hypotension, coded and time of death was reportedly 17:25.Patient has a history of hepatic cirrhosis, dyslipidemia, severe arterial stenosis and hyponatremia.Facility alleges mast cell reaction contributed to reported event.

• Brand Name: POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (70CM GUIDEWIRE)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8500155
• Report Number: 3006260740-2019-00827
• Device Sequence Number: 16740200
• Product Code: LJS
• UDI-Device Identifier: 00801741028113
• UDI-Public: (01)00801741028113
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3295155
• Device Lot Number: RECX0547
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/10/2019
• 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: Death
• Patient Age: 67 YR