MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) SPYGLASS DIRECT VISUALIZATION SYSTEM; SYSTEM, IRRIGATION, UROLOGICAL

Model Number M00546140

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Death (1802)

Event Date 08/25/2017

Event Type  Death  

Manufacturer Narrative

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.

Event Description

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.

Event Description

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.

• Brand Name: SPYGLASS DIRECT VISUALIZATION SYSTEM
• Type of Device: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6885260
• MDR Text Key: 86976124
• Report Number: 3005099803-2017-02848
• Device Sequence Number: 1
• Product Code: LJH
• Combination Product (y/n): N
• PMA/PMN Number: K071832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00546140
• Device Catalogue Number: 4614
• Device Lot Number: 0000001525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death