MAUDE Adverse Event Report: ST. JUDE MEDICAL CPS QUARTET INNER-SUB-ACU 135MEAN 65CM; CATHETER

Model Number	DS2N026-65
Medical Device Problem Codes	Break (1069); Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During an implant procedure, while removing the guide catheter, the catheter broke off inside the patient.The lead was removed and the guide catheter was retrieved successfully.However, the procedure was prolonged.The lead was reinserted successfully using a new guide catheter.The patient was stable with no adverse consequences.
Additional Manufacturer Narrative
A cps catheter with its stop-cock was returned in two pieces for analysis.Visual examination revealed the two portions were broken, the proximal portion of the catheter was fully slit, and white stress marks consistent with the hyper tube rubbing against the wall of the catheter was observed.X-ray inspection of the catheter revealed normal uniform mesh wire and no other anomalies.The reported event was isolated to the slitting technique used during the implant procedure.No device malfunction was found.

• Brand Name: CPS QUARTET INNER-SUB-ACU 135MEAN 65CM
• Common Device Name: CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• MDR Report Key: 7933612
• Report Number: 2182269-2018-00121
• Device Sequence Number: 19396947
• Product Code: DQY
• UDI-Device Identifier: 05415067005724
• UDI-Public: 05415067005724
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K130252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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 Expiration Date: 01/31/2020
• Device Model Number: DS2N026-65
• Device Lot Number: 5845114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 03/27/2019
• 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: Hospitalization; Required Intervention