MAUDE Adverse Event Report: SPECTRANETICS CORPORTATION SPECTRANETICS GLIDELIGHT LASER SHEATH; 14F GLIDELIGHT

Model Number 500-302

Device Problem Physical Resistance (2578)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Excessive Tear Production (2235); Pericardial Effusion (3271)

Event Date 04/30/2014

Event Type  Death  

Event Description

Lead management case to extract one nonfunctional cardiac lead.The lead was prepped with an lld and the physician began lasing with a 14f glidelight; as he passed the arch of the svc the proximal coil was encountered.Gradual progress was made using the glidelight and re-orienting the bevel tip to use as a mechanical dissection over the coil.After passing the coil, resistance was still present but progress continued.A severe drop in bp was noticed and tee showed a growing effusion.The physician attempted intervention for 30 minutes with a pericardiocentesis; however, this was not effective so 45 minutes after the blood pressure dropped, the ct surgeon performed a sternotomy.A large tear was found from the svc down into the heart and across the ventricle, the surgeon determined that this injury was irreparable and the patient did not survive.

• Brand Name: SPECTRANETICS GLIDELIGHT LASER SHEATH
• Type of Device: 14F GLIDELIGHT
• Manufacturer (Section D): SPECTRANETICS CORPORTATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORTATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: sondra chandler rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472530
• MDR Report Key: 3799980
• MDR Text Key: 4476300
• Report Number: 1721279-2014-00071
• Device Sequence Number: 1
• Product Code: MFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 500-302
• Device Catalogue Number: 500-302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2014
• 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
• Treatment: MDT 6949 SPRINT FIDELIS (IMPL. 2006); SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 84