MAUDE Adverse Event Report: ABBOTT CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER; CATHETER, PERCUTANEOUS

Model Number	DS2C023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)
Date of Event	05/03/2022
Type of Reportable Event	Death
Event or Problem Description
Related manufacturer report number: 2017865-2022-10396, 2017865-2022-10397.During a device upgrade procedure, the tendril lead was attempted to be implanted using the hispro catheter.An acceptable implant position could not be found, so a new approach was attempted with a cps direct universal catheter.Lead placement was again unsuccessful, so the hispro catheter was again attempted.At this time, a drop in blood pressure occurred which was successfully resolved with medication.Lead placement was again attempted before the physician elected to abort the implant procedure and remove the hispro catheter.The patient's blood pressure again dropped, however, medication was unsuccessful.Cardiopulmonary resuscitation (cpr) was initiated and maintained for 15 minutes.Chest drainage was performed which revealed bleeding and a hemothorax.Cpr was stopped and the patient was pronounced deceased.The physician suspected a perforation of the superior vena cava occurred early in the procedure when accessing the subclavian vein system.The physician did not allege a malfunction on any abbott product, nor did they allege any abbott product directly caused or contributed to the patient's passing.
Additional Manufacturer Narrative
A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14434597
• Report Number: 2017865-2022-10398
• Device Sequence Number: 17431199
• Product Code: DQY
• UDI-Device Identifier: 05415067004222
• UDI-Public: 05415067004222
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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: 02/29/2024
• Device Model Number: DS2C023
• Device Catalogue Number: DS2C023
• Device Lot Number: 7906526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown