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 2018-03-15 for ULTRA ICE PLUS? M00499100 9910 manufactured by Boston Scientific - Costa Rica (coyol).
[102592786]
It is indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102592787]
It was reported that a catheter break / detachment occurred. An ultra ice plus ultrasound imaging catheter and another manufacturer? S snare were selected for use during an implantable cardioverter defibrillator (icd) lead extraction procedure in the right atrium. During a twisting maneuver with the snare retrieval device, the catheter was entrapped while it was rotating and therefore became damaged. During retrieval of the devices, the piezoelectric crystal broke and detached from the catheter body. It was noted the detachment? Probably? Occurred inside the sheath. All components were removed from the patient without problems and the procedure was completed using a different device. There were no patient complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-01975 |
| MDR Report Key | 7341241 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-15 |
| Date of Report | 2018-02-22 |
| Date of Event | 2018-02-22 |
| Date Mfgr Received | 2018-02-22 |
| Device Manufacturer Date | 2017-05-25 |
| Date Added to Maude | 2018-03-15 |
| 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 | EMP. SONALI ARANGIL |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Manufacturer G1 | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Street | 2546 FIRST STREET PROPARK FREE ZONE |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA ICE PLUS? |
| Generic Name | CATHETER, ULTRASOUND, INTRACARDIAC |
| Product Code | DXK |
| Date Received | 2018-03-15 |
| Model Number | M00499100 |
| Catalog Number | 9910 |
| Lot Number | 20607150 |
| Device Expiration Date | 2019-05-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Address | 2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-15 |