MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-26 for ROTALINK PLUS 3241 manufactured by Boston Scientific Corporation.
[186559740]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[186559741]
It was reported that the burr and wire became separated and remained inside patient. The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified mid right coronary artery. A 1. 25mm rotalink plus and a 330cm rotawire were selected use. During the procedure, the burr went beyond the lesion and was caught in the calcification. Upon trying to withdraw the burr detached within the lesion. In attempts to remove the wire from the burr the wire became caught in the lesion and also separated. Consequently, the separated wire was crimped to blood vessel wall with a stent while the separated burr remained in small side branch between 4av and 4pd. There is no plan on removing the burr so far. The procedure was completed with a different device. No further complications reported, and patient was good post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03852 |
| MDR Report Key | 9883309 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-07-15 |
| Date Added to Maude | 2020-03-26 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORK LIMITED |
| Manufacturer Street | MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTALINK PLUS |
| Generic Name | CATHETER, CORONARY, ATHERECTOMY |
| Product Code | MCX |
| Date Received | 2020-03-26 |
| Model Number | 3241 |
| Catalog Number | 3241 |
| Lot Number | 0024108618 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |