MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER; CATHETER, PERCUTANEOUS

Model Number	DS2C022
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that a patient presented during implant procedure.Upon fluoroscopy, a protruding structure at the tip of the catheter was confirmed.The catheter was taken out from the patient and it was found out that the tip became split.Due to this, the catheter may had been caught at ostium of coronary sinus during insertion.No patient consequences reported.
Additional Manufacturer Narrative
The reported event of the tip became split was confirmed.As received a cps catheter was returned with its hemostasis valve and stop-cock for analysis.Visual examination found the tungsten stripes at the distal tip were damaged/split on both sides.The manufacturing process and dhr was reviewed and no anomalies were identified.Evidence suggests root cause is due to deformation due to compressive stress which likely occurred during the implant procedure.

• Brand Name: CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10955923
• Report Number: 2017865-2020-21833
• Device Sequence Number: 3210587
• Product Code: DQY
• UDI-Device Identifier: 05415067004215
• UDI-Public: 05415067004215
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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 Expiration Date: 02/28/2021
• Device Model Number: DS2C022
• Device Catalogue Number: DS2C022
• Device Lot Number: 6346430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 12/06/2020
• Supplement Report FDA Received Date: 05/05/2021
• 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: Other
• Patient Age: 75 YR
• Patient Weight: 67