MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-09-21 for SPYGLASS DIRECT VISUALIZATION SYSTEM M00546140 4614 manufactured by Boston Scientific - Fremont (ce).
[86976124]
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. However, the complainant reported that the device was not expired. The device has not been received for analysis. Upon receipt and 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.
Patient Sequence No: 1, Text Type: N, H10
[86976125]
Note: this report pertains to two devices used during the same procedure. Manufacturer report # 3005099803-2017-02848 pertains to the spyglass irrigation pump. Manufacturer report # 3005099803-2017-02807 pertains to the spyscope digital access and delivery catheter. It was reported to boston scientific corporation that a spyscope digital access and delivery catheter and a spyglass irrigation pump was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass ds procedure performed on (b)(6) 2017. According to the complainant, during the procedure the patient received conscious sedation, midazolam and fentanol. It was reported that the patient had a plastic stent in situ removed prior to spyscope ds insertion. Reportedly, although the tubing inside the normal saline bottle was curled upwards, the saline irrigation appeared to flow throughout the procedure. The patient experienced a cardiac arrest approximately 10 minutes into the procedure. The patient? S o2 saturation levels dropped and the patient then showed? Physical signs of cerebral- vascular accident?. According to the physician, the air embolism was caused by saline irrigated through the spyscope ds onto trapped air in the left hepatic lobe which was a result of a plastic stent in situ that was removed prior to spyscope ds insertion. This caused air absorption into the venous system. Reportedly, the patient also had an arterial shunt (exact location unknown) which caused the air embolism to become arterial, subsequently, traveling up to the brain causing the cardiac arrest and cerebral event resulting in the patient? S death. The results of the coroner? S inquest will take up to 18 months to be released. Additionally, per the physician the irrigation tube set, the irrigation pump and spyds scope did not contribute to the cardiac arrest. In addition, the manufacturer of the plastic stent is unknown. Reportedly, the customer typically uses cook plastic stents. Attempts were made to get more definitive information regarding this event, however no additional information is available and will only be available unless the post mortem report is provided to boston scientific.
Patient Sequence No: 1, Text Type: D, B5
[105823895]
Patient Sequence No: 1, Text Type: N, H10
[105823896]
Note: this report pertains to two devices used during the same procedure. Manufacturer report # 3005099803-2017-02848 pertains to the spyglass irrigation pump. Manufacturer report # 3005099803-2017-02807 pertains to the spyscope digital access and delivery catheter. It was reported to boston scientific corporation that a spyscope digital access and delivery catheter and a spyglass irrigation pump was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass ds procedure performed on (b)(6) 2017. According to the complainant, during the procedure the patient received conscious sedation, midazolam and fentanol. It was reported that the patient had a plastic stent in situ removed prior to spyscope ds insertion. Reportedly, although the tubing inside the normal saline bottle was curled upwards, the saline irrigation appeared to flow throughout the procedure. The patient experienced a cardiac arrest approximately 10 minutes into the procedure. The patient? S o2 saturation levels dropped and the patient then showed? Physical signs of cerebral- vascular accident?. According to the physician, the air embolism was caused by saline irrigated through the spyscope ds onto trapped air in the left hepatic lobe which was a result of a plastic stent in situ that was removed prior to spyscope ds insertion. This caused air absorption into the venous system. Reportedly, the patient also had an arterial shunt (exact location unknown) which caused the air embolism to become arterial, subsequently, traveling up to the brain causing the cardiac arrest and cerebral event resulting in the patient? S death. The results of the coroner? S inquest will take up to 18 months to be released. Additionally, per the physician the irrigation tube set, the irrigation pump and spyds scope did not contribute to the cardiac arrest. In addition, the manufacturer of the plastic stent is unknown. Reportedly, the customer typically uses cook plastic stents. Attempts were made to get more definitive information regarding this event, however no additional information is available and will only be available unless the post mortem report is provided to boston scientific.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-02848 |
| MDR Report Key | 6885260 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-21 |
| Date of Report | 2017-08-25 |
| Date of Event | 2017-08-25 |
| Date Mfgr Received | 2017-09-22 |
| Device Manufacturer Date | 2010-04-15 |
| Date Added to Maude | 2017-09-21 |
| 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 | 3 |
| Event Location | 3 |
| 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 | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01752 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPYGLASS DIRECT VISUALIZATION SYSTEM |
| Generic Name | SYSTEM, IRRIGATION, UROLOGICAL |
| Product Code | LJH |
| Date Received | 2017-09-21 |
| Model Number | M00546140 |
| Catalog Number | 4614 |
| Lot Number | 0000001525 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - FREMONT (CE) |
| Manufacturer Address | 47215 LAKEVIEW BLVD NORTH DOCK FREMONT CA 94538 US 94538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-09-21 |