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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK VASCULAR INC LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
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COOK VASCULAR INC LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Perforation of Vessels (2135)
Event Date 01/07/2016
Event Type  Injury  
Manufacturer Narrative
Lot # requested but not provided.(b)(4).The event is currently under investigation.
 
Event Description
During extraction of a rv lead by using evolution rl 9f, the tip was very stuck in septum, after drilling tip from septum doctor succeeded to remove lead but caused also a tear through the pericardium rv apex.A thoracotomy was conducted to suture the whole to prevent continuous bleeding.
 
Manufacturer Narrative
(b)(4).Investigation/evaluation: during the course of the investigation, a review of the complaint history of the product was conducted.The device was not returned.There were no images of the device or details of the procedure provided.There is no indication of device failure, nonconformity, or misuse.Based on the limited amount information provided, the root cause of this complaint cannot be determined.However, this is a known failure mode of the device and inherent risk of the lead extraction procedure that is documented in the device instructions for use.We will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.
 
Event Description
During extraction of a rv lead by using evolution rl 9f, the tip was very stuck in septum, after drilling tip from septum doctor succeeded to remove lead but caused also a tear through the pericardium rv apex.A thoracotomy was conducted to suture the whole to prevent continuous bleeding.After a stay in icu the patient recovered very well.
 
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Brand Name
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
Type of Device
DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
Manufacturer (Section D)
COOK VASCULAR INC
1186 montgomery lane
vandergrift PA 15690
Manufacturer Contact
rita harden
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key5396476
MDR Text Key37013407
Report Number1820334-2016-00040
Device Sequence Number1
Product Code DRE
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberLR-EVN-9.0-RL
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/07/2016
Event Location Hospital
Date Manufacturer Received01/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age80 DA
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