MAUDE Adverse Event Report: COOK VASCULAR INC LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Perforation (2511)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Number 510k #: k141148.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The customer reported that, while the lead extraction evolution rl controlled-rotation dilator sheath set was in use over a 1085-64 bsci icd lead with spectranetics lld-ez locking stylet in place to release fibrotic binding sites along the lead, an effusion was detected on the transesophageal echocardiogram.This effusion was detected shortly after the evolution rl reached an area in the right atrium.Cardiothoracic surgery and heart pump team were called immediately.The heart team opened the patient's chest to expose the heart, and the tear in the atrium was repaired.The patient later returned and the leads were successfully snared.The patient is reportedly doing fine.The product is unavailable for return and evaluation.
Additional Manufacturer Narrative
Pma/510(k)# 141148.Investigation summary: the affected product was not returned for physical examination and no photographs were provided.The complaint could only be confirmed through customer testimony.The instructions for use was reviewed and listed as a potential adverse event is 'laceration or tearing of the vascular structures or the myocardium'.This complaint event is a known failure mode and will be monitored and trended via the complain handling and post market processes.A device history record review for this lot number was performed including the manufacturing and quality control records.All steps were documented per procedure by trained personnel and there were no signs to indicate that a nonconforming device was released to the field.The root cause is unable to be determined as the device was not returned in order to complete a physical examination.

• Brand Name: LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
• Common Device Name: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7067039
• Report Number: 2522007-2017-00039
• Device Sequence Number: 13469665
• Product Code: DRE
• UDI-Device Identifier: 10827002237473
• UDI-Public: (01)10827002237473(17)200731(10)N148732
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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 Model Number: N/A
• Device Catalogue Number: LR-EVN-13.0-RL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 04/06/2018
• 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
• Patient Age: 38 YR