MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-17 for CABLE, SURELINK? CABLE FOR DIAGNOSTIC CATHETER M004560001P0 560001P manufactured by Boston Scientific - Costa Rica (heredia).
[108764522]
Device evaluated by mfr: the device has not been received 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 mewatch wil be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[108764523]
It was reported that the blue seal on the package was open (peeled off). The device was not used in a procedure and there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-04378 |
| MDR Report Key | 7521858 |
| Date Received | 2018-05-17 |
| Date of Report | 2018-04-26 |
| Date of Event | 2018-04-26 |
| Date Mfgr Received | 2018-07-18 |
| Device Manufacturer Date | 2018-01-23 |
| Date Added to Maude | 2018-05-17 |
| 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 (HEREDIA) |
| Manufacturer Street | 302 PARKWAY LA AURORA |
| Manufacturer City | HEREDIA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CABLE, SURELINK? CABLE FOR DIAGNOSTIC CATHETER |
| Generic Name | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) |
| Product Code | DSA |
| Date Received | 2018-05-17 |
| Returned To Mfg | 2018-06-05 |
| Model Number | M004560001P0 |
| Catalog Number | 560001P |
| Lot Number | 21647433 |
| 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 (HEREDIA) |
| Manufacturer Address | 302 PARKWAY LA AURORA HEREDIA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-17 |