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 2020-03-09 for SPECTRANETICS 16F GLIDELIGHT LASER SHEATH 500-303 manufactured by The Spectranetics Corporation.
[183891856]
Patient's date of birth unavailable. Patient's weight unavailable. Suspect medical device not established; manufacturer actively seeking additional case detail to identify. Pma/510k number unavailable; suspect medical device not established. Device manufacture date unavailable.
Patient Sequence No: 1, Text Type: N, H10
[183891857]
A lead extraction procedure commenced to remove two right ventricular (rv) leads due to non function. The physician was using a spectranetics 13f tightrail rotating dilator sheath, lead locking devices (lld's) and a 16f glidelight laser sheath, switching between the two leads and between the glidelight and tightrail devices to attempt extraction of the leads, utilizing the lld's for traction on the leads. During the removal of either the glidelight or tightrail device from the patient's body in order to switch to the other device, the patient's blood pressure dropped. It was determined there was an injury. Rescue efforts began immediately, including rescue device, chest compressions and sternotomy. In addition, the extractor did not have a femoral arterial line placed prior to the case, so this was attempted during chest compressions which caused trauma to the patient's femoral artery and femoral vein. When the surgeon opened the patient's chest, a softball size thrombosis was discovered at the neck area of the patient. The patient was successfully put on bypass and the surgeon repaired two tears - one at the bottom of the innominate vein and other at the top of the superior vena cava (svc). The patient survived the procedure, was moved to the hospital floor and seemed stable. The following day, it was determined that the patient was brain dead. All other organs reportedly had no issues and it was hypothesized that the softball size thrombosis may have compressed the patient's carotid arteries and decreased or stopped flow to the brain. Manufacturer is actively seeking additional information in order to provide additional case detail. It is unclear which device likely caused and/or contributed to the areas of injury, and it is unclear the cause and specific location of the thrombosis found in the patient's neck. There was no alleged malfunction of any spectranetics devices used in the procedure.
Patient Sequence No: 1, Text Type: D, B5
[183900039]
This follow up report is being submitted so the report can be processed, although we have received no additional information regarding the procedure details at this time. Although it cannot be confirmed that the suspect device in use at the time of the innominate and superior vena cava (svc) injuries, it has been confirmed that the spectranetics 16f glidelight device was in use in the area, along with a spectranetics 13f tightrail rotating dilator sheath, as stated in the initial mdr. Device information now populated captures the 16f glidelight laser sheath. There was no lot number or expiration date available for this device at this time. Device manufacture date is unavailable because the device lot number is unavailable. There remains no information regarding the cause and location of the thrombosis found in the patient''s neck.
Patient Sequence No: 1, Text Type: N, H10
[183901261]
Additional information: on (b)(6) 2020, the rep spoke to the physician regarding case detail for this event. It was reported that the right atrial lead was removed when the sternotomy was performed, but the right ventricular icd lead remained within the patient's body. The physician stated he felt that the cause of the patient's death was possibly a stroke like event, possibly from a thrombus during rescue, since there were no kidney or liver issues noted; some type of secondary neurological event. The glidelight device was confirmed to be in use when the injuries occurred to the innominate and svc areas. It was also reported by the physician that he did not think that any spectranetics devices caused the thrombus that was found at the neck area of the patient. Corrected information: on 12 march 2020, it was reported to postmarket surveillance by the rep that there were three leads being extracted during the procedure: one active rv lead, one capped rv lead, and an ra lead. The information reported in the initial mdr stated that two rv leads were being extracted. This supplemental #2 mdr is being submitted to provide the additional case detail provided by the physician and to correct the information initially provided regarding the number of leads being extracted during the procedure.
Patient Sequence No: 1, Text Type: N, H10
[183901826]
In the initial mdr, the manufacturer was awaiting additional information, so conclusions was used for this section. However, when the manufacturer received additional procedure detail and with the submission of supplemental report #2, updating this conclusion code was inadvertently missed. Conclusions code accurately reflects the injuries the patient sustained during this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721279-2020-00047 |
| MDR Report Key | 9805971 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-01-23 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-16 |
| Date Added to Maude | 2020-03-09 |
| 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 |
| Brand Name | SPECTRANETICS 16F GLIDELIGHT LASER SHEATH |
| Generic Name | GLIDELIGHT |
| Product Code | MFA |
| Date Received | 2020-03-09 |
| Model Number | 500-303 |
| Catalog Number | 500-303 |
| 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 |
| Product Code | --- |
| Date Received | 2020-03-09 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-09 |