MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR ALPHACURVE CHRONIC DL CATHETER 14.5 FR., 31CM; LONG-TERM HEMODIALYSIS CATHETER

Model Number 5835270

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Perforation (2001); Cardiac Tamponade (2226)

Event Type  Death  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 07/2020).

Event Description

It was reported that during catheter placement the guidewire allegedly perforated the heart and cardiac tamponade occurred requiring intervention, which resulted in the patient expiring.

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date: 07/2020.

Event Description

It was reported that during catheter placement the guidewire allegedly perforated the heart and cardiac tamponade occurred requiring intervention, which resulted in the patient expiring.

• Brand Name: HEMOSTAR ALPHACURVE CHRONIC DL CATHETER 14.5 FR., 31CM
• Type of Device: LONG-TERM HEMODIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8616962
• MDR Text Key: 145278752
• Report Number: 3006260740-2019-01402
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013515
• UDI-Public: (01)00801741013515
• Combination Product (y/n): N
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5835270
• Device Catalogue Number: 5835270
• Device Lot Number: RECX2774
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death