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
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/05/2017
Type of Reportable Event	Malfunction
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.A lot history review (lhr) of rebv0150 showed no other similar product complaint(s) from this lot number.(b)(4).
Event or Problem 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
• 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: 7429973
• Report Number: 3006260740-2018-00702
• Device Sequence Number: 84143
• Product Code: FOZ
• UDI-Device Identifier: 00801741140495
• UDI-Public: (01)00801741140495
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2018
• Report Date (Section F): 02/27/2018

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
• Operator of Device: 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/27/2018