MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-06-06 for ULTRA ICE PLUS? M00499120 9912 manufactured by Boston Scientific - Costa Rica (coyol).
[76745347]
(b)(4). The device has not been returned for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76745348]
Same case as: 2134265-2017-05584. It was reported that tip detachment occurred. An ultra ice? Diagnostic catheter was selected for use. During the procedure, the physician used the first ultra ice? , however, it was noticed that the tip of ultra ice? Was detached after long use and the catheter stopped spinning. Another ultra ice? Was used but the same issue occurred. The procedure was completed with using the third ultra ice? Diagnostic catheter. No patient complications were reported and the patient's status was stable.
Patient Sequence No: 1, Text Type: D, B5
[107228543]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[107228544]
It was further reported that the tip detaches within the catheter housing. It doesn't actually detach itself into the patient. The catheter itself remains intact. There was/is an issue with the weld at the tip point.
Patient Sequence No: 1, Text Type: D, B5
[110514312]
Device evaluated by mfr: the device was returned for analysis. Device analysis revealed the transducer distal housing was found detached from the drive cable. Evidence of the 6 weld points was found in the distal housing and drive cable. All the diameter measurements are within the specifications. It was observed that the catheter flushed normally. Impedance testing shows an electrical open at distal wave form. Full image characterization cannot be performed due to detachment. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause was unable to be determined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[110514313]
Same case as: 2134265-2017-05584. It was reported that tip detachment occurred. An ultra ice? Diagnostic catheter was selected for use. During the procedure, the physician used the first ultra ice? , however, it was noticed that the tip of ultra ice? Was detached after long use and the catheter stopped spinning. Another ultra ice? Was used but the same issue occurred. The procedure was completed with using the third ultra ice? Diagnostic catheter. No patient complications were reported and the patient's status was stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2017-05583 |
| MDR Report Key | 6614398 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-06 |
| Date of Report | 2017-05-17 |
| Date of Event | 2017-05-17 |
| Date Mfgr Received | 2017-09-27 |
| Device Manufacturer Date | 2017-03-16 |
| Date Added to Maude | 2017-06-06 |
| 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 | 2017-06-06 |
| Returned To Mfg | 2017-06-09 |
| Model Number | M00499120 |
| Catalog Number | 9912 |
| Lot Number | 20395875 |
| Device Expiration Date | 2019-03-13 |
| 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 - COSTA RICA (COYOL) |
| Manufacturer Address | 2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-06 |