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 Problems Unspecified Infection (1930); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2020

Event Type  Injury  

Manufacturer Narrative

(initial reporter facility name): (b)(4).(initial reporter city, state): (b)(4).(study): e7107 intraoperative pancreatoscopy (iop) in intraductal papillary mucinous neoplasm of the pancreas (ipmn).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 spyscope ds ii access and delivery catheter was used in the pancreas during a procedure performed on (b)(6) 2020 as part of the e7107 intraoperative pancreatoscopy (iop) in intraductal papillary mucinous neoplasm of the pancreas (ipmn) study.According to the complainant, before the patient underwent the study procedure, the patient was given pre-operative antibiotics for one day.During the procedure, the spyscope ds ii was used with good quality imaging.A pancreatoscope was then advanced along the entire length of the main pancreatic duct (mpd), with a depth of insertion within the mpd of 60 mm.Reportedly, the patient has a normal duct and normal macroscopic appearance of the tissue.They collected pancreatic juice and there was no biopsy obtained as there were no lesions noted.The patient also underwent a surgical procedure of robotic pylorus-resecting pancreaticoduodenectomy (prpd).On (b)(6) 2020, the patient had severe hepaticojejunostomy (hj) leakage.Reportedly, based on clavien-dindo classification, the patient is grade iii a, requiring surgical, endoscopic or radiologic intervention (intervention not under general anesthesia).The patient was hospitalized and was given antibiotics.In addition, collections of percutaneous drainage were also done.During the patient's follow-up on (b)(6) 2020, there was no recurrence of intraductal papillary mucinous neoplasm of the pancreas noted.As of (b)(6) 2020, the patient has not recovered.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

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) 2020 as part of the e7107 intraoperative pancreatoscopy (iop) in intraductal papillary mucinous neoplasm of the pancreas (ipmn) study.According to the complainant, before the patient underwent the study procedure, the patient was given pre-operative antibiotics for one day.During the procedure, the spyscope ds ii was used with good quality imaging.A pancreatoscope was then advanced along the entire length of the main pancreatic duct (mpd), with a depth of insertion within the mpd of 60 mm.Reportedly, the patient has a normal duct and normal macroscopic appearance of the tissue.They collected pancreatic juice and there was no biopsy obtained as there were no lesions noted.The patient also underwent a surgical procedure of robotic pylorus-resecting pancreaticoduodenectomy (prpd).On (b)(6) 2020, the patient had severe hepaticojejunostomy (hj) leakage.Reportedly, based on clavien-dindo classification, the patient is grade iii a, requiring surgical, endoscopic or radiologic intervention (intervention not under general anesthesia).The patient was hospitalized and was given antibiotics.In addition, collections of percutaneous drainage were also done.During the patient's follow-up on (b)(6) 2020, there was no recurrence of intraductal papillary mucinous neoplasm of the pancreas noted.As of (b)(6) 2020, the patient has not recovered.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.The following additional information was received from the clinical site on february 01, 2021: on (b)(6) 2020, the patient had severe delayed gastric emptying which was categorized as grade iii a based on clavien-dindo classification, requiring surgical, endoscopic or radiologic intervention (intervention not under general anesthesia).The patient was hospitalized and a nasogastric tube and stomach pump were placed.On (b)(6) 2021, the patient had severe hj stenosis which was also categorized as grade iii a, requiring surgical, endoscopic or radiologic intervention (intervention not under general anesthesia).The patient was hospitalized and was given ceftriaxone and metronidazol.A percutaneous drain was placed and dilatation stenosis was performed on the patient by an interventional radiologist.The patient's adverse events of severe delayed gastric emptying, severe hj stenosis, and severe hj leakage have been confirmed to be not related to the spyscope ds ii access and delivery catheter.The patient's adverse events were causally related to the index surgical procedure.

Manufacturer Narrative

Block e1 (initial reporter facility name): (b)(6).Block e1 (initial reporter city, state): (b)(6).Block g3 (study): e7107 intraoperative pancreatoscopy (iop) in intraductal papillary mucinous neoplasm of the pancreas (ipmn).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 problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

• 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: 11047128
• MDR Text Key: 222691441
• Report Number: 3005099803-2020-06235
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

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 Expiration Date: 01/28/2022
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0025127566
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 02/04/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 72 YR