MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-05-17 for SPYGLASS DIRECT VISUALIZATION SYSTEM M00546230 4623 manufactured by Boston Scientific - Marlborough.
[15775125]
It was reported to boston scientific corporation that a spyscope access and delivery catheter was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to remove a large stone on (b)(6) 2013. According to the complainant, during the procedure, the spyscope pushed through the wall of the bile duct. The procedure was abandoned and the patient was sent to surgery. The preoperative diagnoses were right pneumothorax, pneumomediastinum and free introabdominal air. The patient underwent an exploratory laparotomy. The patient had esophagogastroduodenoscopy (egd) done during surgery to evaluate the duodenal injury. A bronchoscopy was performed to check for aspiration, but the patient's lungs had cleared. Postoperative diagnoses were right pneumothorax and perforated duodenum at the second/third portion of the retroperitoneal location. The patient was on a vent and chest tube. The patient was reported to have recovered ok. The total time in the hospital is unknown, but was discharged sometime prior to (b)(6) 2013. The patient's condition has been described as ok.
Patient Sequence No: 1, Text Type: D, B5
[15981332]
The complainant was unable to provide the suspect device lot number; therefore, the device expiration date and device manufacture date 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 | 3005099803-2013-03977 |
| MDR Report Key | 3118518 |
| Report Source | 05,07 |
| Date Received | 2013-05-17 |
| Date of Report | 2013-04-26 |
| Date of Event | 2013-04-25 |
| Date Mfgr Received | 2013-04-26 |
| Date Added to Maude | 2013-05-17 |
| 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. INGRID MATTE |
| 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 | 2013-05-17 |
| 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 | 2013-05-17 |