MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2017-08-10 for SPECTRANETICS CORONARY LASER ATHERECTOMY CATHETER 110-004 manufactured by Spectranetics.
[82443900]
Patient weight is not available from the facility.
Patient Sequence No: 1, Text Type: N, H10
[82443901]
It was reported that during a coronary vascular intervention procedure to treat a 90% stenosis in the lad, a perforation occurred. Reportedly, an elca device was used for the treatment. There was no problem lasing at a low fluence/rate setting, so it was increased. After 5 passes with the device, the physician performed a confirmation cag which revealed a perforation at the middle of the target lesion. A balloon catheter was used for hemostasis and it was successful. A graft was placed due to an aneurysm that was identified. The procedure was completed successfully and the patient was transferred to ccu.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2017-00162 |
| MDR Report Key | 6784969 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER |
| Date Received | 2017-08-10 |
| Date of Report | 2017-07-19 |
| Date of Event | 2017-07-19 |
| Date Mfgr Received | 2017-07-19 |
| Device Manufacturer Date | 2017-03-04 |
| Date Added to Maude | 2017-08-10 |
| 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 | MR. NICK MCNABB |
| Manufacturer Street | 9965 FEDERAL DRIVE |
| Manufacturer City | COLORADO SPRINGS CO 80921 |
| Manufacturer Country | US |
| Manufacturer Postal | 80921 |
| Manufacturer Phone | 719447-257 |
| Manufacturer G1 | SPECTRANETICS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRANETICS CORONARY LASER ATHERECTOMY CATHETER |
| Generic Name | ELCA |
| Product Code | LPC |
| Date Received | 2017-08-10 |
| Model Number | 110-004 |
| Catalog Number | 110-004 |
| Lot Number | FHH17C04A |
| ID Number | NI |
| Device Expiration Date | 2019-03-08 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECTRANETICS |
| Manufacturer Address | 9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2017-08-10 |