MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 7 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUF; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	7711700
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reap1987 showed no other similar product complaint(s) from this lot number.Device, not yet returned.
Event or Problem Description
It was reported that the nurse first noted the blue pressure hub wouldn't attach properly to the groshong port.The guide wire remained in the catheter and a blunt flush cap was attached to the guidewire's hub.After placement the physician initially stated that there wasn't a guide wire in place and this was confirmed by an x-ray where no guidewire could be seen.Further examination indicated there was in fact a wire left inside the patient.They believe it was left inside the patient because it had broken off of the original cap.After the surgeon removed the wire it was compared to a fresh groshong catheter kit, they noted no appearance of damage to the wire, both wires measured 19.5 inches and they surmised that nothing remained in the patient.No patient injury was reported.

• Brand Name: GROSHONG 7 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUF
• 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: 6895304
• Report Number: 3006260740-2017-01707
• Device Sequence Number: 808047
• Product Code: LJS
• UDI-Device Identifier: 00801741036736
• UDI-Public: (01)00801741036736
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/26/2017
• Report Date (Section F): 08/17/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 7711700
• Device Catalogue Number: 7711700
• Device Lot Number: REAP1987
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2017
• 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: Required Intervention
• Patient Age: 74 YR
• Date Report Sent to FDA: 08/17/2017