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 Code	Vascular Dissection (3160)
Date of Event	01/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During implant, the sheath of the outer catheter caused a coronary sinus dissection during cannulation.The left ventricular lead implantation was discontinued.No additional intervention was performed and the patient was in stable condition.
Additional Manufacturer Narrative
As received, a catheter with hemostasis valve and stop-cock was returned in one piece for analysis.Visual examination did not reveal any anomalies with the exception of procedural damage.

• Brand Name: CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9707191
• Report Number: 2017865-2020-01484
• Device Sequence Number: 14366118
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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: 07/31/2022
• Device Model Number: DS2C023
• Device Catalogue Number: DS2C023
• Device Lot Number: 7153516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 03/31/2020
• 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: Required Intervention