MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DISCOVER DIGITAL CATHETER

Model Number 4678

Device Problem Difficult to Advance (2920)

Patient Problem Perforation (2001)

Event Date 09/17/2021

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: patient's exact age is unknown; however it was reported that the patient was over the age of 18.(product code): ntn.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a spyglass discover digital catheter was used in the cystic duct, common bile duct, and intra-hepatic ducts during a living donor liver hepatectomy procedure performed on (b)(6) 2021.During the procedure, the surgeon was trying to pass the spyglass discover digital catheter through the cystic duct, into the common bile duct, and up into the hepatic ducts to visualize the intra-hepatic ducts.The patient's cystic duct was very small and it was difficult to get the spyglass catheter into the duct.The surgeon used a dilation balloon to widen the cystic duct opening and then inserted a guidewire through the cystic duct into the common bile duct and then tried to use the guidewire as a rail over which to pass the spyglass discover catheter to gain access into the common bile duct.These attempts were unsuccessful and the surgeon decided to abort this portion of the procedure and proceeded with completing the transplant in his usual method.Post procedure, perforation was noticed in the distal common bile duct/cystic duct common bile duct confluence of the patient.In the physician's assessment, the spy discover catheter contribute to patient's perforation as the cystic duct and the common bile ducts of the patient was very small and had a hard time accommodating the catheter.The size of the catheter made it challenging to access the targeted anatomy.Two follow up endoscopic retrograde cholangiopancreatography (ercp) procedure was performed to manage the perforation and bile leak.It was reported that the patient is expected to fully recover.

• Brand Name: SPYGLASS DISCOVER DIGITAL CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12697614
• MDR Text Key: 278362627
• Report Number: 3005099803-2021-05595
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: 08714729994183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200483
• 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
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4678
• Device Catalogue Number: M00546780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention