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 2014-08-12 for SPYGLASS DIRECT VISUALIZATION SYSTEM M00546230 4623 manufactured by Boston Scientific - Marlborough.
[21807068]
It was reported to boston scientific corporation that a spyscope access & delivery catheter was used in the biliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2014. According to the complainant, during the procedure, the spyscope was inspected and tested prior to use with no issues noted. A non-bsc laser device was being used in conjunction with the spyscope access & delivery catheter to break a stone. Difficulty was encountered when advancing the non-bsc laser device through the spyscope. After manipulating the laser several times, they found a? Little piece of plastic came out of the sheath of the scope? And fell into the patient which was retrieved using biopsy forceps. A second spyscope access & delivery catheter was used with the laser to complete the procedure. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
[22089184]
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18. Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[32222395]
Working channel evaluation found that the spybite passed through the working channel and exited the distal end with no issues. The returned device was found to have a small piece of plastic, which did not come from the spyscope device and it is unknown as to where it originated from. Based on the condition of the returned device and the evaluation conducted, a definitive root cause for the reported failure could not be determined; therefore, the root cause classification is undeterminable. The review and analysis of all available information fails to indicate a root cause or probable root cause for the reported event. A review of the device history record (dhr) was performed and no anomalies were noted. A search of the complaint database revealed that no similar complaints exist for the specified lot. Labeling review was performed and no anomalies were found.
Patient Sequence No: 1, Text Type: N, H10
[32222396]
It was reported to boston scientific corporation that a spyscope access & delivery catheter was used in the biliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2014. According to the complainant, during the procedure, the spyscope was inspected and tested prior to use with no issues noted. A non-bsc laser device was being used in conjunction with the spyscope access & delivery catheter to break a stone. Difficulty was encountered when advancing the non-bsc laser device through the spyscope. After manipulating the laser several times, they found a? Little piece of plastic came out of the sheath of the scope? And fell into the patient which was retrieved using biopsy forceps. A second spyscope access & delivery catheter was used with the laser to complete the procedure. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2014-02821 |
| MDR Report Key | 4003991 |
| Report Source | 00,01,05,07 |
| Date Received | 2014-08-12 |
| Date of Report | 2014-07-17 |
| Date of Event | 2014-07-17 |
| Date Mfgr Received | 2014-09-25 |
| Device Manufacturer Date | 2013-12-10 |
| Date Added to Maude | 2014-08-12 |
| 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. NANCY CUTINO |
| 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 | 2014-08-12 |
| Returned To Mfg | 2014-07-18 |
| Model Number | M00546230 |
| Catalog Number | 4623 |
| Lot Number | ML00001907 |
| Device Expiration Date | 2014-11-30 |
| 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 | 1. Required No Informationntervention | 2014-08-12 |