MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-10 for ROTAWIRE AND WIRECLIP TORQUER 3520 manufactured by Boston Scientific Corporation.
[182798244]
Age at time of event: 18 years or below.
Patient Sequence No: 1, Text Type: N, H10
[182798245]
It was reported that the wire got separated and required additional intervention. The 10mm-15mmx3. 0mm in diameter, 100% stenosed target lesion area was located in a mildly tortuous and severely calcified left anterior descending artery (lad). A 1. 25mm rotalink plus was selected for use along with a 330cm rotawire. During the first procedure using 1. 5 burr, the device was unable to pass through the lesion. The device was replaced with a 1. 25 burr. The device was set at 220,000 rpm and a stall occurred right after starting ablation. Ablation was performed by the rotational burr being moved forward and backward all the time without staying one place. The rotawire floppy got separated upon the first ablation. The vessel in the left main trunk (lmt) got damaged. Subsequently, hemostasis was performed on the injured part using a non-bsc perfusion balloon, but when a non-bsc coronary stent was placed the laterocavernous sinus got occluded completely. The wire was removed by pulling it out. However, the separated wire remained inside the lad. A coronary bypass was done and completely retrieved the separated guidewire from the patient's body. The patient was stable following the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02804 |
| MDR Report Key | 9811909 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2019-08-14 |
| Date Added to Maude | 2020-03-10 |
| 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 | 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 CORPORATION |
| Manufacturer Street | 302 PARKWAY, GLOBAL PARK |
| Manufacturer City | LA AURORA - HEREDIA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTAWIRE AND WIRECLIP TORQUER |
| Generic Name | CATHETER, CORONARY, ATHERECTOMY |
| Product Code | MCX |
| Date Received | 2020-03-10 |
| Returned To Mfg | 2020-03-12 |
| Model Number | 3520 |
| Catalog Number | 3520 |
| Lot Number | 0024266604 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-10 |