MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BROVIAC 6.6 FR SINGLE-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	Venipuncture (2129)
Date of Event	03/16/2017
Type of Reportable Event	Serious Injury
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 huzd1973 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility: "general endotracheal anesthesia was induced.The chest and neck were prepped and draped in a standard sterile fashion using betadine paint.Access attempt was made from the left subclavian position.There was return of nonpulsatile blood.A wire was advanced using the seldinger technique without resistance.The wire was seen across the midline by fluoroscopic guidance and the right border of the heart.It was felt to be safely in a venous position.At this point, a counter incision was made in the left anterior chest wall.A 0.5% bupivacaine was infiltrated in skin and subcutaneous tissues at the site.A 6.6 french broviac catheter was tunneled from the anterior chest wall site towards the vessel puncture site and delivered.It was measured to appropriated size and cut.Next, under direct fluoroscopic guidance, a 7 french peel away sheath introducer was advanced over the wire towards the heart.Again, it crossed the midline and turned towards the right heart border.Next, the obturator from the peel away sheath was removed in order to place the catheter forward.At this time, we encountered bright red high pressure bloody return.End result was endovascular interrogation of aortic cannulation.Median sternotomy with repair of puncture at aortic arch as well as left subclavian vein was performed.¿ there were no issues with the device.On 04/03/2017-the facility reported that the patient had another central line placed and was returning to baseline with plans to be discharged.

• Brand Name: BROVIAC 6.6 FR SINGLE-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6505005
• Report Number: 3006260740-2017-00444
• Device Sequence Number: 14733
• Product Code: LJS
• UDI-Device Identifier: 00801741051838
• UDI-Public: (01)00801741051838(17)200528(10)HUZD1973
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2017
• Report Date (Section F): 03/17/2017

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: 05/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 0600544
• Device Lot Number: HUZD1973
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/16/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2017
• 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: Life Threatening
• Patient Age: 8 YR
• Patient Weight: 29
• Date Report Sent to FDA: 03/17/2017