MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER SPYSCOPE DS ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00546600

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2017.According to the complainant, during preparation, after the device was removed from the packaging, the spyscope ds tip hit the floor.An alcohol wipe was used to wipe the tip and they continued to use this device.Reportedly, there was no visible damage with the device.The spyscope ds was advanced through the endoscopic retrograde cholangiopancreatography (ercp) scope and when the image appeared there were lines across the screen.The procedure was completed with a second spyscope ds.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 fine.

Manufacturer Narrative

A visual examination of the spyscope ds was performed and no damage was noted on the device and its components.A functional inspection was performed.The device was plugged into the controller.The image displayed was pixelated.The device camera and wires was further analyzed through real-time x-ray.When the lead and umbilicus were manipulated and articulated, pixelated lines appeared intermittently.The complaint was consistent with the reported event of poor image quality.The most probable root cause for the reported complaint incident of ¿not sterile¿ is handling damage.A most probable root cause of handling damage indicates that the issue was caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation, at the end of the procedure, or when packaging for return.A dhr (device history record) review was performed and no deviation was found.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2017.According to the complainant, during preparation, after the device was removed from the packaging, the spyscope ds tip hit the floor.An alcohol wipe was used to wipe the tip and they continued to use this device.Reportedly, there was no visible damage with the device.The spyscope ds was advanced through the endoscopic retrograde cholangiopancreatography (ercp) scope and when the image appeared there were lines across the screen.The procedure was completed with a second spyscope ds.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 fine.

• Brand Name: SPYSCOPE DS ACCESS & DELIVERY CATHETER
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6674224
• MDR Text Key: 78610768
• Report Number: 3005099803-2017-01970
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: (01)08714729863236(17)20190228(10)20270831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2019
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 20270831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2017
• Initial Date FDA Received: 06/28/2017
• Supplement Dates Manufacturer Received: 07/17/2017
• Supplement Dates FDA Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1