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

Model Number M00546610

Device Problems Optical Problem (3001); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.(device codes): problem code 3191 is being used to capture the reportable event of aborted/cancelled procedure.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 mdr will be filed.

Event Description

Note: this report pertains to the second of two spyscope ds ii used during the same procedure.It was reported to boston scientific corporation that two spyscope ds ii access & delivery catheters were used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noticed that the image of the first spyscope ds ii was lost when it was inserted into the common bile duct.A second spyscope ds ii was used; however, the same problem occured.The procedure was not completed due to this event.Reportedly, a plastic stent was placed and the procedure was rescheduled.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

Block h6 (device codes): problem code 3191 is being used to capture the reportable event of aborted/cancelled procedure.Block h6 (evaluation conclusion codes): conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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.

Event Description

Note: this report pertains to the second of two spyscope ds ii used during the same procedure.It was reported to boston scientific corporation that two spyscope ds ii access & delivery catheters were used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2020.According to the complainant, during the procedure, it was noticed that the image of the first spyscope ds ii was lost when it was inserted into the common bile duct.A second spyscope ds ii was used; however, the same problem occured.The procedure was not completed due to this event.Reportedly, a plastic stent was placed and the procedure was rescheduled.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 II ACCESS & DELIVERY CATHETER
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11108684
• MDR Text Key: 224791718
• Report Number: 3005099803-2020-06567
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• PMA/PMN Number: K181439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

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: Health Professional
• Device Expiration Date: 09/05/2022
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 25973462
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1