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 2020-03-23 for SPECTRANETICS 16F GLIDELIGHT LASER SHEATH 500-303 manufactured by The Spectranetics Corporation.
[186722230]
A lead extraction procedure commenced to remove a right atrium (ra) and a right ventricle (rv) lead due to cied system/pocket infection. There were multiple devices used by the physician to aid in the removal of the leads. The rv lead was extracted successfully. During removal of ra lead with the spectranetics 16 fr glidelight laser sheath, the patient's blood pressure dropped. Fluoroscopy showed that the right lung collapsed and had filled with blood. Rescue intervention commenced immediately. A chest tube was placed on the patient'' right side and a small hole in the heart was determined by digital subtraction angiography (dsa). After about ten minutes, the small 3mm hole in svc had sealed off by coagulation or clotting. The chest tube had an output of 1600ml. Pressure normalized and the patient's reimplantation was scheduled for the following day. Reimplantation was successful and the patient survived the procedures. There was no reported malfunction of the spectranetics devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00057 |
| MDR Report Key | 9869301 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-27 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-23 |
| 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 | 2020-03-23 |
| Model Number | 500-303 |
| Catalog Number | 500-303 |
| Lot Number | FGC19M14A |
| 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 | 2020-03-23 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-23 |