MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-03-19 for SPYGLASS DIRECT VISUALIZATION SYSTEM M00546230 4623 manufactured by Boston Scientific - Marlborough.
[2409319]
It was reported to boston scientific corporation that a spyscope access and delivery catheter was used during an ercp (endoscopic retrograde cholangiopancreatography) procedure on (b)(6), 2012. According to the complainant, during the ercp procedure the physician reported that a small yellow tubular piece of plastic was found in the patient. Prior to the fragment being found, a rx extraction balloon and olympus scope had been used with no reported malfunctions. The physician claims that the fragment had detached from the spyscope, however could not report any visible damage to the device. The fragment was unable to be recovered and was passed in the patient's stool. The procedure was completed with the same spyscope with no patient complications. There were no issues or harm to the patient reported.
Patient Sequence No: 1, Text Type: D, B5
[9696444]
(b)(4):the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. The complainant indicated that the device was disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2012-01036 |
| MDR Report Key | 2495678 |
| Report Source | 05,07 |
| Date Received | 2012-03-19 |
| Date of Report | 2012-02-27 |
| Date of Event | 2012-02-24 |
| Date Mfgr Received | 2012-02-27 |
| Date Added to Maude | 2012-03-19 |
| 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 | EMP. CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | MEDVENTURE TECHNOLOGY CORPORATION |
| Manufacturer Street | 2301 CENTENNIAL BOULEVARD |
| Manufacturer City | JEFFERSONVILLE IN 47130 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPYGLASS DIRECT VISUALIZATION SYSTEM |
| Generic Name | MINI ENDOSCOPE, GASTROENTEROLOGY-UROLOGY |
| Product Code | ODF |
| Date Received | 2012-03-19 |
| Model Number | M00546230 |
| Catalog Number | 4623 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-19 |