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

Model Number M00546610

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/12/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access and delivery catheter was used in the pancreas during a procedure performed on (b)(6) 2021 as part of the e7107 intraoperative pancreatoscopy (iop) in intraductal papillary mucinous neoplasm of the pancreas (ipmn) study.During the procedure, the scope was advanced along the entire main pancreatic duct (mpd) with excellent image quality.The indication of the procedure was a main pancreatic duct (mpd) dilation greater than or equal to 10mm on imaging.The procedure was completed with the original spyscope ds ii.No biopsy was completed and an open pylorus preserving pancreatoduodectomy (pppd) was performed as planned with no additional procedures completed.On (b)(6) 2021, the patient was hospitalized due to severe bleeding in the gastric duodenal artery and a stent was placed in the gastro duodenal artery via an interventional radiologist.This event was given a grade iv clavien-dindo classification.On (b)(6) 2021, the patient had severe a lung embolism which was categorized as grade ii based on clavien-dindo classification, requiring pharmacological treatment with drugs other than such allowed for grade 1 complications.Heparin was given to the patient.On (b)(6) 2021, the patient had a moderate delayed gastric emptying which was categorized as grade ii based on clavien-dindo classification, requiring pharmacological treatment with drugs other than such allowed for grade 1 complications.A gastric tube was placed within the patient.On (b)(6) 2021, it was indicated that the patient had not recovered in relation to the three onset events.

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

Block h6 (patient codes): the patient code e0506 captures the reportable event of patient severe hemorrhage/bleeding.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 problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: additional information: b5.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access and delivery catheter was used in the pancreas during a procedure performed on (b)(6) 2021 as part of the e7107 intraoperative pancreatoscopy (iop) in intraductal papillary mucinous neoplasm of the pancreas (ipmn) study.During the procedure, the scope was advanced along the entire main pancreatic duct (mpd) with excellent image quality.The indication of the procedure was a main pancreatic duct (mpd) dilation greater than or equal to 10mm on imaging.The procedure was completed with the original spyscope ds ii.No biopsy was completed and an open pylorus preserving pancreatoduodectomy (pppd) was performed as planned with no additional procedures completed.On (b)(6) 2021, the patient was hospitalized due to severe bleeding in the gastric duodenal artery and a stent was placed in the gastro duodenal artery via an interventional radiologist.This event was given a grade iv clavien-dindo classification.On (b)(6) 2021, the patient had severe a lung embolism which was categorized as grade ii based on clavien-dindo classification, requiring pharmacological treatment with drugs other than such allowed for grade 1 complications.Heparin was given to the patient.On (b)(6) 2021, the patient had a moderate delayed gastric emptying which was categorized as grade ii based on clavien-dindo classification, requiring pharmacological treatment with drugs other than such allowed for grade 1 complications.A gastric tube was placed within the patient.On (b)(6) 2021, it was indicated that the patient had not recovered in relation to the three onset events.Additional information: based on additional information received on january 5, 2022, it was confirmed that the gastric duodenal artery bleeding was unlikely related to the spyscope ds ii device and procedure, and the lung embolism and gastric emptying were not related to the spyscope ds ii and procedure.Based on additional information received on january 5, 2022, it was indicated that the patient had recovered on (b)(6) 2021.

• 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
• 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: 12924447
• MDR Text Key: 281673902
• Report Number: 3005099803-2021-06274
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K181439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

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: 01/27/2023
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0026702095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• 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; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male