SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH 560-013

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-07 for SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH 560-013 manufactured by The Spectranetics Corporation.

Event Text Entries

[176787140] Patient age unavailable, date of birth unavailable. Patient weight unavailable. Device lot number and expiration date unavailable. Device manufacture date unavailable because lot number is unavailable.
Patient Sequence No: 1, Text Type: N, H10

[176787141] A lead extraction procedure commenced to remove two leads: a right atrial (ra) lead and a right ventricular (rv) lead due to non function. Spectranetics lead locking devices (lld's) were place in both leads to provide traction on the leads during removal attempts. A spectranetics glidelight laser sheath was used first to attempt removal of the rv lead but the physician experienced stalled progression in the innominate vein. He then utilized a spectranetics medium 43cm visisheath along with the 14f glidelight, but could not get down to the superior vena cava (svc) on either lead. The physician then chose to use a 16f glidelight device with a large 33cm visisheath and could advance a little further down the leads. He then chose to use a spectranetics 13f tightrail device on both the ra and rv leads, and although the physician still had traction, the leads looked like they were unraveling. He met stalled progression where the innominate vein transitioned into the svc. There appeared to be a large calcification on both leads right near the svc, so the physician switched to a spectranetics 13f tightrail sub-c device. He was able to make some progress as he attempted to remove the ra lead, but during this time, the ra lead and the lld within the ra lead broke (please reference mdr 1721279-2020-00005 which captures the lld breaking). The physician then switched attempt to remove the rv lead. As he was advancing the tightrail sub-c device past the lead on lead binding high in the right atrium, he pulled the device back off the rv lead, which was still fixed in the right ventricle. At this point, the patient's blood pressure dropped. Rescue efforts began immediately. A sternotomy was performed, an svc tear was discovered, and was successfully repaired. Both the ra and rv leads were removed post sternotomy, after the repair was complete. The patient survived the procedure. This report is being submitted to capture the svc tear which occurred during the procedure while the tightrail sub-c device was in use.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1721279-2020-00004
• MDR Report Key: 9559521
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-01-07
• Date of Report: 2019-12-11
• Date of Event: 2019-12-11
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-03-11
• Date Added to Maude: 2020-01-07
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS. BARBARA CREEL
• Manufacturer Street: 9965 FEDERAL DRIVE
• Manufacturer City: COLORADO SPRINGS CO 80921
• Manufacturer Country: US
• Manufacturer Postal: 80921
• Manufacturer Phone: 719447-246
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH
• Generic Name: TIGHTRAIL
• Product Code: DRE
• Date Received: 2020-01-07
• Model Number: 560-013
• Catalog Number: 560-013
• Lot Number: UNAVAILABLE
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: THE SPECTRANETICS CORPORATION
• Manufacturer Address: 9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-01-07
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention	2020-01-07