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

Model Number M00546780

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

Patient Problem Inflammation (1932)

Event Date 05/20/2022

Event Type  Injury  

Manufacturer Narrative

Product code: ntn.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a device analysis could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to a spyscope ds ii and an advanix biliary stent used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii and an advanix biliary stent were used during a percutaneous cholecystostomy procedure performed in the gall bladder on (b)(6) 2022.During the procedure, spyglass discover was used via percutaneous cholecystostomy to assist with gall bladder stone removal.The interventional radiologist was unable to grab stones using spyglass retrieval basket due to difficult anatomy.After dilating cystic duct, some stones were able to pass through the cystic duct.An advanix biliary plastic stent was also deployed to help with drainage.The patient developed infection post procedure (cholecystitis) and was admitted to intensive care unit (icu).No further information obtained as to whether spyglass contributed to patient's infection.It was reported that the patient was fully recovered from icu.

Manufacturer Narrative

Block h6: patient code e2326 captures the reportable event of infection.Impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.Block h6 (evaluation conclusion codes): conclusion code d17 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 device analysis could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: correction - block b5 (describe event or problem) has been corrected.Correction: block g5 (premarket / 510(k) #) has been corrected.

Event Description

Note: this report pertains to a spy discover catheter and an advanix biliary stent used during the same procedure.It was reported to boston scientific corporation that a spy discover catheter and an advanix biliary stent were used during a percutaneous cholecystostomy procedure performed in the gall bladder on (b)(6) 2022.During the procedure, spyglass discover was used via percutaneous cholecystostomy to assist with gall bladder stone removal.The interventional radiologist was unable to grab stones using spyglass retrieval basket due to difficult anatomy.After dilating cystic duct, some stones were able to pass through the cystic duct.An advanix biliary plastic stent was also deployed to help with drainage.The patient developed infection post procedure (cholecystitis) and was admitted to intensive care unit (icu).No further information obtained as to whether spyglass contributed to patient's infection.It was reported that the patient was fully recovered from icu.

• 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: 15021200
• MDR Text Key: 295950561
• Report Number: 3005099803-2022-03794
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: 08714729994183
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K200483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

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 Expiration Date: 11/27/2023
• Device Model Number: M00546780
• Device Catalogue Number: 4678
• Device Lot Number: 0028458226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2021
• 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): Hospitalization