MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-18 for SPECTRANETICS 16F GLIDELIGHT LASER SHEATH 500-303 manufactured by The Spectranetics Corporation.
[180211440]
Patient date of birth unavailable. Device lot number unavailable. Device expiration date unavailable. Device manufacture date unavailable because lot number is unavailable.
Patient Sequence No: 1, Text Type: N, H10
[180211441]
A lead extraction procedure commenced to remove two right ventricle (rv) leads and one right atrium (ra) lead due to redundancy. The ra lead was being pulled back into the superior vena cava (svc) for extraction using a spectranetics 16f glidelight laser sheath. The lead was encased in a fibrous adhesion. The physician aligned the glidelight as axially as possible to the lead, which came back abruptly into the glidelight upon application of laser energy. At that point, the glidelight's device tip inadvertently and suddenly moved up against the outer curve of the svc and the physician immediately stopped lasing. The patient was stable after the procedure and was being monitored. However, approximately six hours post procedure, the patient's blood pressure dropped, and a chest x-ray confirmed a haemothorax. The physician placed a chest drain in the patient, and underwent video assisted thoracoscopy to confirm that no further bleeding was occurring. No further intervention was warranted, and the patient survived the procedure. There was no alleged malfunction of any spectranetics devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00035 |
| MDR Report Key | 9723277 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-18 |
| Date of Report | 2020-01-24 |
| Date of Event | 2020-01-09 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-24 |
| Date Added to Maude | 2020-02-18 |
| 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 | MS. NICOLE WORFORD |
| 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 |
| Brand Name | SPECTRANETICS 16F GLIDELIGHT LASER SHEATH |
| Generic Name | GLIDELIGHT |
| Product Code | MFA |
| Date Received | 2020-02-18 |
| Model Number | 500-303 |
| Catalog Number | 500-303 |
| Lot Number | UNAVAILABLE FROM FACILITY |
| 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 |
| Product Code | --- |
| Date Received | 2020-02-18 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-02-18 |