MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-10-29 for SPYGLASS DIRECT VISUALIZATION PROBE M00546030 4603 manufactured by Boston Scientific Corporation.
[967589]
Note: this report pertains to the second of two devices used in this procedure. Refer to manufacturer report #3005099803-2008-005577 for details regarding the other device. It was reported to boston scientific corporation that following a procedure using a spyglass direct visualization probe (male patient weight is unknown), free air was found near the diaphragm; there was no contrast in this space. According to the complainant, the patient presented with an "elevated white count," but was not feverish. It was further reported that additional evaluation led to a belief that a micro perforation had occurred around the sphincterotomy site. The patient was in icu and their condition at the conclusion of the procedure was reported to be "stable and improving. "
Patient Sequence No: 1, Text Type: D, B5
[8213316]
The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date is unknown. According to the complainant, the suspect device has been disposed and is not available for return. A device evaluation cannot be performed; the cause of the reported malfunction is undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-05576 |
| MDR Report Key | 1216232 |
| Report Source | 05,07 |
| Date Received | 2008-10-29 |
| Date of Report | 2008-09-30 |
| Date of Event | 2008-09-26 |
| Date Mfgr Received | 2008-09-30 |
| Date Added to Maude | 2008-11-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEN HIRAKAWA |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836264 |
| Manufacturer G1 | MYRIAD FIBER IMAGING TECHNOLOGIES INC. |
| Manufacturer Street | 56 SOUTHBRIDGE ROAD |
| Manufacturer City | DUDLEY MA 01571 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01571 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPYGLASS DIRECT VISUALIZATION PROBE |
| Product Code | ODF |
| Date Received | 2008-10-29 |
| Model Number | M00546030 |
| Catalog Number | 4603 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1265766 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2008-10-29 |