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 2019-02-11 for SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER 114-009 manufactured by The Spectranetics Corporation.
[135883088]
Patient weight was unavailable from the site. It has been requested that the device be returned. However, it has not been sent back.
Patient Sequence No: 1, Text Type: N, H10
[135883089]
A philips representative reported that during coronary atherectomy procedure due to in-stent re-stenosis of the right coronary artery(rca), the tip of the spectranetics coronary laser atherectomy catheter (elca) (b)(4) appeared to have become detached during the procedure. An intravascular ultrasound (ivus) run was performed prior to the laser catheter being inserted. Multiple laser passes were made followed by angioplasty. At that point the physician decided to make additional passes with the elca laser catheter. The physician used a combination of saline infusions and contrast infusions while making passes with the laser catheter. The attempts post angioplasty is when it appeared that catheter tip had become detached from the catheter. Upon removing the laser catheter the. 014 guide-wire was retracted, angio-grams were performed, and the guide-wire was re-inserted. The guide-wire was advanced and as a result the catheter tip became wedged/lodged in the distal rca vasculature. There appeared to be no adverse effect to the patient as a result of the events. At that point the physician made the determination to stop the procedure. No additional procedures/interventions performed for removal of device tip. The device tip remains in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2019-00015 |
| MDR Report Key | 8329637 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-11 |
| Date of Report | 2019-01-16 |
| Date of Event | 2019-01-16 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2018-11-09 |
| Date Added to Maude | 2019-02-11 |
| 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 | MISS CATHERINE EATON |
| Manufacturer Street | 9965 FEDERAL DRIVE |
| Manufacturer City | COLORADO SPRINGS CO 80921 |
| Manufacturer Country | US |
| Manufacturer Postal | 80921 |
| Manufacturer Phone | 719447-246 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER |
| Generic Name | ELCA |
| Product Code | LPC |
| Date Received | 2019-02-11 |
| Model Number | 114-009 |
| Catalog Number | 114-009 |
| Lot Number | FH118L09A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE SPECTRANETICS CORPORATION |
| Manufacturer Address | 9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-11 |