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

Model Number	5835270
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Death (1802); Perforation (2001); Cardiac Tamponade (2226)
Type of Reportable Event	Death
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: LONG-TERM HEMODIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8616962
• Report Number: 3006260740-2019-01402
• Device Sequence Number: 16952922
• Product Code: MSD
• UDI-Device Identifier: 00801741013515
• UDI-Public: (01)00801741013515
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5835270
• Device Catalogue Number: 5835270
• Device Lot Number: RECX2774
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 05/30/2019
• 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: Death