MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-03-31 for SPYSCOPE ACCESS AND DELIVERY CATHETER M00546230 4623 manufactured by Boston Scientific - Marlborough.
[1295001]
Note: this report pertains to one of five devices that were used in the same procedure. Refer to manufacturer report # 3005099803-2010-01651, 3005099803-2010-01658, 3005099803-2010-01654 and 3005099803-2010-01670 for the other associated device information. It was reported to boston scientific corporation that a spyglass direct visualization probe, a spyscope access and delivery catheter, an autotome rx sphincterotome, a dreamwire, and a extractor rx retrieval balloon were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b) (6) 2010. During the ercp procedure, a dreamwire guidewire was inserted into the duodenal scope and positioned within the common bile duct. The physician then passed an autotome device over the dreamwire. The autotome was removed from the patient. An extractor balloon was used to remove several stones from the common bile duct. The extractor balloon was deflated and removed from the patient. The spyglass system was then used to inspect the common bile duct. The spyglass probe and access & delivery catheter were positioned within the duct; the duct was observed to be normal with minor debris. The spyglass probe and access & delivery catheter were removed from the patient. At this time, the patient desaturated and a code was called by the anesthesiologist. The patient expired immediately after the removal of the device. No abnormalities or device malfunctions were reported during the ercp procedure. At this time, the facility does not attribute the patient death to any bsc product used during the case. The facility would not release the autopsy report, however they stated that the report indicated "no known cause of death" and they saw nothing in the autopsy to indicate that there were any issues in the area that the ercp was performed.
Patient Sequence No: 1, Text Type: D, B5
[1484902]
Note: this report pertains to one of five devices that were used in the same procedure. Refer to manufacturer report # 3005099803-2010-01651, 3005099803-2010-01658, 3005099803-2010-01654 and 3005099803-2010-01670 for the other associated device information. It was reported to boston scientific corporation that a spyglass direct visualization probe, a spyscope access and delivery catheter, an autotome rx sphincterotome, a dreamwire, and a extractor rx retrieval balloon were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b) (6) 2010. During the ercp procedure, a dreamwire guidewire was inserted into the duodenal scope and positioned within the common bile duct. The physician then passed an autotome device over the dreamwire. The autotome was removed from the patient. An extractor balloon was used to remove several stones from the common bile duct. The extractor balloon was deflated and removed from the patient. The spyglass system was then used to inspect the common bile duct. The spyglass probe and access & delivery catheter were positioned within the duct; the duct was observed to be normal with minor debris. The spyglass probe and access & delivery catheter were removed from the patient. At this time, the patient desaturated and a code was called by the anesthesiologist. The patient expired immediately after the removal of the device. No abnormalities or device malfunctions were reported during the ercp procedure. At this time, the facility does not attribute the patient death to any bsc product used during the case. The facility would not release the autopsy report; however, they stated that the report indicated "no known cause of death" and they saw nothing in the autopsy to indicate that there were any issues in the area that the ercp was performed.
Patient Sequence No: 1, Text Type: D, B5
[8662749]
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 of 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. (b) (4)
Patient Sequence No: 1, Text Type: N, H10
[8664965]
Follow up information received by the complainant revealed that the patient was being treated for choledocolithiasis. All the stones were removed. The patient coded during the procedure due to the lack of oxygen caused by an obstruction or issue related to the anesthesia. The complainant would not offer information regarding the patient? S medical history. (b) (4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2010-01653 |
| MDR Report Key | 1647500 |
| Report Source | 05,07 |
| Date Received | 2010-03-31 |
| Date of Report | 2010-03-09 |
| Date of Event | 2010-03-09 |
| Date Mfgr Received | 2010-04-01 |
| Date Added to Maude | 2010-04-09 |
| 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 | MR. 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 | SPYSCOPE ACCESS AND DELIVERY CATHETER |
| Generic Name | MINI ENDOSCOPE, GASTROENTEROLOGY-UROLOGY |
| Product Code | ODF |
| Date Received | 2010-03-31 |
| Model Number | M00546230 |
| Catalog Number | 4623 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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. Death | 2010-03-31 |