SPECTRANETICS 16F GLIDELIGHT LASER SHEATH 500-303

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-01-10 for SPECTRANETICS 16F GLIDELIGHT LASER SHEATH 500-303 manufactured by The Spectranetics Corporation.

Event Text Entries

[177008132] Patient date of birth unavailable. Patient weight unavailable.
Patient Sequence No: 1, Text Type: N, H10

[177008133] A lead extraction procedure commenced to remove two leads: a right atrial (ra) lead and a right ventricular (rv) lead due to infection. The physician attempted to retract the screws on the distal ends of the rv and ra but were unsuccessful. Spectranetics lead locking devices (ldl's) were placed inside each lead to provide traction. The physician began using a spectranetics 14f glidelight device for lead removal attempt, but encountered stalled progression in the subclavian region. A spectranetics 10f sightrail device was then used with no further progress. The team then attempted to use a snare from a femoral insertion site but was unsuccessful. They then used a metal sheath (cook medical) and were able to get progress using this, along with the glidelight and sightrail devices. They encountered stalled progression in the superior vena cava (svc) region. The physician then upsized to a 16f glidelight device; however the patient's blood pressure dropped. There was no sign of a cardiac effusion but a shadow was noticed in the patient's right chest. The patient was transferred to icu and there it was confirmed that the patient's blood pressure continued to drop. It was decided to commence rescue efforts, including sternotomy. A small hole was discovered at the svc/ra junction. The repair to the hole was successfully completed. Both the ra and rv leads and ldl's within them were cut, capped, and remained in the patient, and it was noted that the physician did not attempt to unlock either lld prior to cutting and capping the leads/ldl's. There is no reported malfunction of any spectranetics devices used in the procedure. The patient survived. This report captures the injury to the svc/ra junction while the glidelight device was in use.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1721279-2020-00007
• MDR Report Key: 9575624
• Report Source: DISTRIBUTOR,FOREIGN,HEALTH PR
• Date Received: 2020-01-10
• Date of Report: 2019-12-16
• Date of Event: 2019-12-13
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2019-12-16
• Device Manufacturer Date: 2019-06-12
• Date Added to Maude: 2020-01-10
• 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 16F GLIDELIGHT LASER SHEATH
• Generic Name: GLIDELIGHT
• Product Code: MFA
• Date Received: 2020-01-10
• Model Number: 500-303
• Catalog Number: 500-303
• Lot Number: FGC19F12A
• 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: 2020-01-10
• 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	2020-01-10