MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-06-23 for CAPIO STANDARD 831-232 manufactured by Boston Scientific Corp..
[469027]
It was reported that a therapeutic sling procdure was performed where this capio device became stuck in pt tissue after six firings. The physician was able to remove the device successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000111-2005-00007 |
| MDR Report Key | 689814 |
| Report Source | 05,06 |
| Date Received | 2005-06-23 |
| Date of Report | 2005-06-14 |
| Date of Event | 2004-10-28 |
| Date Mfgr Received | 2005-06-14 |
| Device Manufacturer Date | 2004-06-01 |
| Date Added to Maude | 2006-03-21 |
| 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 | 0 |
| Manufacturer Contact | NANCY CUTINO |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760 |
| Manufacturer Phone | 5086834066 |
| Manufacturer G1 | A DIV OF BOSTON SCIENTIFIC CORP. |
| Manufacturer Street | 8600 N.W. 41ST STREET |
| Manufacturer City | MIAMI FL 33166620 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33166 6202 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPIO STANDARD |
| Generic Name | SUTURING SYSTEM |
| Product Code | MCZ |
| Date Received | 2005-06-23 |
| Returned To Mfg | 2004-11-03 |
| Model Number | NA |
| Catalog Number | 831-232 |
| Lot Number | 6639577 |
| ID Number | NA |
| Device Expiration Date | 2005-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 678991 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | 8600 N.W. 41ST ST MIAMI FL 331666202 US |
| Baseline Brand Name | CAPIO SUTURE CAPTURING DEVICE |
| Baseline Generic Name | SUTURING DEVICE |
| Baseline Model No | NA |
| Baseline Catalog No | 831-232 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-06-23 |