MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA CATHETER WITH SOLO VALVE TECHNOLOGY AND SHERLOCK 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Material Fragmentation (1261); Material Deformation (2976)

Patient Problems Death (1802); Septic Shock (2068)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rect1642 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the rn when to place the picc in the patient brachial vein.The rn accessed the vein and went to thread wire and it got stuck in the vein.The rn applied a warm compress to the site and waited but was unable to remove the wire.The surgeon came in and "yanked" on the wire and pulled it out.It was stated the upon removal the wire was unraveled.A ct scan showed 4 cm left in patient and the fragment was removed.The patient was septic and died sometime after the event.It was stated that the death was not due to this procedure.

• Brand Name: POWERPICC PROVENA CATHETER WITH SOLO VALVE TECHNOLOGY AND SHERLOCK 3CG
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 8118566
• MDR Text Key: 128860439
• Report Number: 3006260740-2018-03433
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741112751
• UDI-Public: (01)00801741112751
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2018

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: S1395108D
• Device Lot Number: RECT1642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention