MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO HF CATHETER 5F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)(135CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Material Frayed (1262)

Patient Problem Death (1802)

Event Date 02/14/2020

Event Type  Death  

Manufacturer Narrative

The information provided by bd 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 bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recx0146 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported via medwatch "retained wire discovered on post post-procedure x-ray inside patient's right ventricle.".

• Brand Name: POWERPICC SOLO HF CATHETER 5F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)(135CM)
• 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: 10548290
• MDR Text Key: 207376287
• Report Number: 3006260740-2020-03288
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741028373
• UDI-Public: (01)00801741028373
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/24/2020,09/17/2020

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 Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 3395335Q
• Device Lot Number: RECX0146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2020
• Distributor Facility Aware Date: 02/14/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• 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): Death
• Patient Age: 30 YR