MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,07 report with the FDA on 2011-11-17 for SPYGLASS DIRECT VISUALIZATION SYSTEM M00546230 4623 manufactured by Boston Scientific - Marlborough.
[2352507]
It was reported to boston scientific corporation that a spyscope delivery catheter was used during a gallstone fragmentation procedure on (b)(6) 2011. According to the complaint, during the procedure, the spyscope was used along with a laser to successfully complete the procedure, but upon removal from the endoscope, the physician noted a crack near the distal end of the device. No resistance was encountered during the procedure and no part of the spyscope detached. There were no patient complications and the patient's condition has been described as good.
Patient Sequence No: 1, Text Type: D, B5
[2424329]
It was reported to boston scientific corporation that a spyscope delivery catheter was used during a gallstone fragmentation procedure on (b)(6), 2011. According to the complaint, during the procedure the spyscope was used along with a laser to successfully complete the procedure , but upon removal from the endoscope the physician noted a crack near the distal end of the device. No resistance was encountered during the procedure and no part of the spyscope detached. There were no patient complications and the patient's condition has been described as good.
Patient Sequence No: 1, Text Type: D, B5
[9488872]
Although, the exact patient information is unknown, the patient is over 18 years of age. (b)(4) for the reported event of catheter cracked. Although, the suspect device has been received, the evaluation has not yet been completed. Upon 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
[9623195]
A visual examination of the returned device revealed that a 1mm split was present near the distal tip. The condition of the returned incident device was consistent with the complaint that the distal end of the catheter was cracked. The evaluation identified a split in the catheter near the distal tip. This damage may have occurred during the manufacturing process. Therefore, the most probable root cause is supplier manufacture. There is an open supplier corrective action to address this issue. A review of the device history record (dhr) was performed; no anomalies were noted. A search of the complaint database revealed that no similar complaints exist for the specified lot. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2011-03926 |
| MDR Report Key | 2340696 |
| Report Source | 00,01,05,07 |
| Date Received | 2011-11-17 |
| Date of Report | 2011-10-24 |
| Date of Event | 2011-10-24 |
| Date Mfgr Received | 2012-01-18 |
| Device Manufacturer Date | 2011-06-02 |
| Date Added to Maude | 2011-11-17 |
| 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 | 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 | 2011-11-17 |
| Returned To Mfg | 2011-10-28 |
| Model Number | M00546230 |
| Catalog Number | 4623 |
| Lot Number | ML00000114 |
| Device Expiration Date | 2012-05-31 |
| 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 - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-17 |