SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH 545-511

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 2020-03-17 for SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH 545-511 manufactured by The Spectranetics Corporation.

Event Text Entries

[184075953] Patient's weight unavailable.
Patient Sequence No: 1, Text Type: N, H10

[184075994] A lead extraction procedure commenced to remove a right ventricular (rv)pacing lead due to occlusion, and being upgraded to an icd lead. There was a right atrial (ra) lead, a left ventricular (lv) lead and a second rv lead present in the patient as well, but were not targeted for lead extraction. Multiple spectranetics devices along with concomitant devices were in use during the procedure: spectranetics 14f and 16f glidelight laser sheaths, tightrail rotating dilator sheath, lead locking devices (lld's) and cook medical evolution device. During the extraction attempt, the physician reportedly used a 14f glidelight first. Due to stalled progress, he then used a cook evolution device, followed by an 11f tightrail device, and lastly a 16f glidelight device. The physician was able to free the helix of the lead, and significant adhesions were noted on the end of the lead. He attempted to pull the lead back through the glidelight device in order to remove it. However, as he was pulling the lead back, the end of the lead flipped around, but ultimately was successfully removed. After the rv lead was extracted, the patient's blood pressure dropped. Rescue efforts commenced immediately, including sternotomy. Perforations to the superior vena cava (svc) and to the right atrial appendage were discovered (please see mdr 1721279-2020-00054 which captures the right atrial appendage injury, in which the lld was used as the traction platform to aid in lead removal). Interventions were successful and the patient survived the procedure. The physician could not be certain, but thinks that the tightrail or the evolution devices may have caused or contributed to the svc tear. The physician believes that the helix of the rv lead actually tore the atrial appendage when it flipped around during lead removal. This report captures the tightrail device, which the physician believes may have caused or contributed to the svc tear found during rescue.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1721279-2020-00052
• MDR Report Key: 9842074
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-03-17
• Date of Report: 2020-02-24
• Date of Event: 2020-02-21
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-02-24
• Date Added to Maude: 2020-03-17
• 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 ROTATING DILATOR SHEATH
• Generic Name: TIGHTRAIL
• Product Code: DRE
• Date Received: 2020-03-17
• Model Number: 545-511
• Catalog Number: 545-511
• Lot Number: FRK18M12A
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• 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: 2020-03-17
• 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	2020-03-17