MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 22G 8CM RT BASIC KIT WITH GUARDIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number F122087T

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/05/2017

Event Type  malfunction  

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.A lot history review (lhr) of rebv0150 showed no other similar product complaint(s) from this lot number.(b)(4).

Event Description

It was reported that during insertion of catheter, the catheter broke with the wire remaining threaded through the lumen.It was stated that the clinician was unable to fully withdraw wire and broken catheter.Surgeon was consulted.

• Brand Name: PG PRO 22G 8CM RT BASIC KIT WITH GUARDIVA
• 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: 7429973
• MDR Text Key: 105675212
• Report Number: 3006260740-2018-00702
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140495
• UDI-Public: (01)00801741140495
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2018,04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: F122087T
• Device Catalogue Number: F122087T
• Device Lot Number: REBV0150
• 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: 02/27/2018
• Distributor Facility Aware Date: 10/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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