MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-05 for SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER 114-009 manufactured by The Spectranetics Corporation.
[180209097]
Patient's date of birth and age unavailable. Patient's weight unavailable. Device evaluation: both the elca device and marker band were returned to the manufacturer and were evaluated on 30 january 2020. Upon evaluation, the proximal and distal end of the band shows no damage. The external surface of the band shows scuff marks. In the spectranetics instructions for use (ifu), 4. Indications for use, treating underexpanded stents is not listed as an indication for use. This event's indication for use is considered to be off-label and unapproved.
Patient Sequence No: 1, Text Type: N, H10
[180209098]
A coronary vascular intervention procedure commenced. The procedure indication was reported to treat underexpanded stents present in the mid left anterior descending (lad) artery. The physician used a spectranetics elca device and successfully completed ten passes with the device in this area. When the physician pulled the elca catheter out through the stents, the radiopaque marker band (normally present at the device's' distal tip) detached in the patient's artery. A sapphire balloon was used to retrieve the marker band successfully. The patient survived the procedure with no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00023 |
| MDR Report Key | 9672537 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-09 |
| 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 | 2020-01-09 |
| Date Added to Maude | 2020-02-05 |
| 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 ELCA CORONARY ATHERECTOMY CATHETER |
| Generic Name | ELCA |
| Product Code | LPC |
| Date Received | 2020-02-05 |
| Returned To Mfg | 2020-01-27 |
| Model Number | 114-009 |
| Catalog Number | 114-009 |
| Lot Number | FH118L09A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-02-05 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-05 |