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 02/11/2022

Event Type  Injury  

Manufacturer Narrative

Pro code: ntn.Initial reporter address: (b)(6).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

It was reported to boston scientific corporation that a spyglass discover digital catheter was used during a percutaneous transhepatic cholangiography (ptc) procedure on (b)(6) 2022.The patient was enrolled in the spyglass discover percutaneous study no.(b)(6).During the procedure, the spyglass discover advanced to the target and target lesions/stones were visualized.A guidewire was used to assist the advancement of the spyglass discover during the ptc.Mechanical, electrohydraulic or laser clearance of biliary stones/sludge was completed and an intraductal drain remained in place for the safety of the subject.On (b)(6) 2022, the patient experienced cholangitis and was hospitalized and treated with antibiotic therapy.A cholangiography was also performed on (b)(6) 2022, but no residual lithiasis was observed.The biliary drainage was replaced and the patient was reported to be fine after receiving antibiotic therapy.

Event Description

It was reported to boston scientific corporation that a spyglass discover digital catheter was used during a percutaneous transhepatic cholangiography (ptc) procedure on february 10, 2022.The patient was enrolled in the spyglass discover percutaneous study no.(b)(6).During the procedure, the spyglass discover advanced to the target and target lesions/stones were visualized.A guidewire was used to assist the advancement of the spyglass discover during the ptc.Mechanical, electrohydraulic or laser clearance of biliary stones/sludge was completed and an intraductal drain remained in place for the safety of the subject.On (b)(6) 2022, the patient experienced cholangitis and was hospitalized and treated with antibiotic therapy.A cholangiography was also performed on (b)(6) 2022, but no residual lithiasis was observed.The biliary drainage was replaced and the patient was reported to be fine after receiving antibiotic therapy.Additional information was received on june 17, 2022: the physician stated that it is typical to hospitalize patients as standard of care for four to five days and that there was no delayed discharge due to the event.

Manufacturer Narrative

Block d2b: pro code ntn.Block e1: initial reporter address: gastroenterology & digestive endoscopy endoscopy agostino gemelli irccs.Correction: block h6 (patient codes): the patient code e2326 captures the reportable event of patient cholangitis.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 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.Block h11 additional information: block b2 (outcomes attrib to adv event), block b5 (describe event or problem).Block h6 (impact codes).

• 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: 13594951
• MDR Text Key: 288027486
• Report Number: 3005099803-2022-01010
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: 08714729994183
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K200483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

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: 05/10/2023
• Device Model Number: M00546780
• Device Catalogue Number: 4678
• Device Lot Number: 0027281908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 06/17/2022
• Supplement Dates FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female