ROTAPRO
Report
- Report Number
- 2124215-2024-36883
- Event Type
- Injury
- Date Received
- June 18, 2024
- Date of Event
- May 28, 2024
- Report Date
- September 16, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MCX
- UDI-DI
- 08714729893363
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
E1 - INITIAL REPORTER ADDRESS 1: (B)(6) HOSPITAL .
E1 - INITIAL REPORTER ADDRESS 1: (B)(6). H6 - DEVICE CODES: ADDED DETACHMENT OF DEVICE OR DEVICE COMPONENT A0501, STRETCHED A040611, MATERIAL SEPARATION A0413. B5 - DESCRIBE EVENT OR PROBLEM: THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, AN ANALYSIS WAS CONCLUDED BASED ON THE PHOTO PROVIDED BY THE SITE SHOWING A DETACHED BURR AND STRETCHED AND DETACHED COIL.
B5 - DESCRIBE EVENT OR PROBLEM: UPDATED. E1 - INITIAL REPORTER ADDRESS 1: (B)(6) HOSPITAL. DEVICE EVALUATED BY MFR: INSPECTION OF THE DEVICE FOUND THAT THE COIL WAS STRETCHED AND DETACHED AT THE BURR. THE BURR WAS DETACHED AND WAS FOUND RETURNED ON THE RETURNED ON A PORTION OF THE INCOMPLETE ROTAWIRE OF WHICH THE BURR WAS ABLE TO BE FULLY REMOVED WITH NO ISSUE OR RESISTANCE. INSPECTION OF THE DEVICE FOUND NO FURTHER DAMAGES OR DEFECTS.
IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION AND PATIENT UNDERWENT SURGERY. A 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS OSTIAL CIRCUMFLEX ARTERY. A 1.50 ROTABURR WAS SELECTED FOR USE. DURING THE PROCEDURE, RESISTANCE WAS FELT WHEN TRYING TO EXIT THE WIRE THROUGH THE PROXIMAL END OF THE ADVANCER. UPON REMOVING THE WIRE, IT WAS NOTED TO BE A LITTLE KINKED IN THE PROXIMAL TIP OF THE WIRE. THE BENT WAS MODIFIED, AND PROGRESS WAS MADE WITHOUT PROBLEM. ABLATION WAS COMPLETED WITHOUT COMPLICATIONS HOWEVER, THE PHYSICIAN NOTICED THAT THERE WAS RESISTANCE. WHEN TRYING TO REMOVE THE BURR, THE GUIDE CATHETER LOST ITS OSTIAL POSITION IN HIS OPINION. THE PROXIMAL PART OF THE BURR WAS STUCK TO THE AORTA AND DID NOT ALLOW THE GUIDE CATHETER TO BE REINSERTED. THEY TRIED TO SNARE WITHOUT SUCCESS. PING PONG WAS ATTEMPTED WITH A SECOND WIRE, MANAGING TO CHANNEL AGAIN SUCCESSFULLY, BUT WITHOUT SUCCESS IN REMOVING THE BURR. OTHER OPTIONS WERE STOPPED, AND BY-PASS SURGERY WAS PERFORMED.
IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION AND PATIENT UNDERWENT SURGERY. A 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS OSTIAL CIRCUMFLEX ARTERY. A 1.50 ROTABURR WAS SELECTED FOR USE. DURING THE PROCEDURE, RESISTANCE WAS FELT WHEN TRYING TO EXIT THE WIRE THROUGH THE PROXIMAL END OF THE ADVANCER. UPON REMOVING THE WIRE, IT WAS NOTED TO BE A LITTLE KINKED IN THE PROXIMAL TIP OF THE WIRE. THE BENT WAS MODIFIED, AND PROGRESS WAS MADE WITHOUT PROBLEM. ABLATION WAS COMPLETED WITHOUT COMPLICATIONS HOWEVER, THE PHYSICIAN NOTICED THAT THERE WAS RESISTANCE. WHEN TRYING TO REMOVE THE BURR, THE GUIDE CATHETER LOST ITS OSTIAL POSITION IN HIS OPINION. THE PROXIMAL PART OF THE BURR WAS STUCK TO THE AORTA AND DID NOT ALLOW THE GUIDE CATHETER TO BE REINSERTED. THEY TRIED TO SNARE WITHOUT SUCCESS. PING PONG WAS ATTEMPTED WITH A SECOND WIRE, MANAGING TO CHANNEL AGAIN SUCCESSFULLY, BUT WITHOUT SUCCESS IN REMOVING THE BURR. OTHER OPTIONS WERE STOPPED, AND BY-PASS SURGERY WAS PERFORMED.
IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION AND PATIENT UNDERWENT SURGERY. A 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS OSTIAL CIRCUMFLEX ARTERY. A 1.50 ROTABURR WAS SELECTED FOR USE. DURING THE PROCEDURE, RESISTANCE WAS FELT WHEN TRYING TO EXIT THE WIRE THROUGH THE PROXIMAL END OF THE ADVANCER. UPON REMOVING THE WIRE, IT WAS NOTED TO BE A LITTLE KINKED IN THE PROXIMAL TIP OF THE WIRE. THE BENT WAS MODIFIED, AND PROGRESS WAS MADE WITHOUT PROBLEM. ABLATION WAS COMPLETED WITHOUT COMPLICATIONS HOWEVER, THE PHYSICIAN NOTICED THAT THERE WAS RESISTANCE. WHEN TRYING TO REMOVE THE BURR, THE GUIDE CATHETER LOST ITS OSTIAL POSITION IN HIS OPINION. THE PROXIMAL PART OF THE BURR WAS STUCK TO THE AORTA AND DID NOT ALLOW THE GUIDE CATHETER TO BE REINSERTED. THEY TRIED TO SNARE WITHOUT SUCCESS. PING PONG WAS ATTEMPTED WITH A SECOND WIRE, MANAGING TO CHANNEL AGAIN SUCCESSFULLY, BUT WITHOUT SUCCESS IN REMOVING THE BURR. OTHER OPTIONS WERE STOPPED, AND BY-PASS SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1331685 | ROTAPRO | CATHETER, CORONARY, ATHERECTOMY | MCX | BOSTON SCIENTIFIC CORPORATION | 3243 | 08714729893363 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention| O |