MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS VISISHEATH DILATOR SHEATH

Model Number UNKNOWN

Device Problem Kinked (1339)

Patient Problems Laceration(s) (1946); Vascular Dissection (3160)

Event Date 06/13/2017

Event Type  Injury  

Event Description

Complex procedure to extract 4 leads: 2 active (ra and rv) and 2 capped (ra and rv).The active ra and rv leads were successfully extracted.The capped leads had significant lead on lead binding present, and a visisheath device was in use among other devices.The visisheath was advanced with considerable force at the left brachiocephalic vein area, and at one point kinked to a right angle bend approximately 4 cm from the distal end.The rep reported 20-30 point arterial pressure drops, and pressors were administered to the patient.Leads removed; reimplant of new pacing system completed; but later in day, a sternotomy was performed to repair a discovered dissected left brachiocephalic vein and a small laceration on the carotid artery, near the aortic arch.Patient survived procedure.

• Brand Name: SPECTRANETICS VISISHEATH DILATOR SHEATH
• Type of Device: VISISHEATH
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 6688030
• MDR Text Key: 79119206
• Report Number: 1721279-2017-00135
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNAVAILABLE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2017

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
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 07/05/2017
• 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 Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 53 YR