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

Model Number M00546610

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 11/28/2022

Event Type  Injury  

Manufacturer Narrative

(senior nurse endoscopy phone number): senior nurse endoscopy: (b)(6).(b)(4).

Event Description

Note: note: this report pertains to the spyscope ds ii access & delivery catheter and spyglass ds controller used during the same procedure.Refer to manufacturer report# 3005099803-2022-07963 for the spyscope ds ii access & delivery catheter and 3005099803-2023-00001 for the spyglass ds controller.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass ds controller were used during a cholangiopancreatography examination procedure performed on (b)(6) 2022.During the procedure, the spyscope ds ii did not work.They made several attempts; however, it was unsuccessful.Another technique was performed during the examination which was guided by rx device.It was reported that the patient's health condition was severe that required life-sustaining intervention.Vasoactive medications were given, orotracheal intubation and surgical intervention was performed by the physician.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block e1 (senior nurse endoscopy phone number): senior nurse endoscopy: (b)(6).Block h6: patient code e2401 captures the reportable event of unspecified injury.Impact code f12 captures the reportable event of surgical intervention.Impact code f23 captures the reportable event of unexpected medical intervention.Block h10: the returned spyscope ds ii was analyzed, and a visual evaluation noted that no elevator marks were seen on the shaft of the catheter.An image assessment for visualization was performed.Upon plugging the device into the controller, a live image was displayed.Articulation of the catheter had no effect on the image.X-ray imaging of the distal tip showed no problems with the redistribution layer (rdl).No camera wire damage was observed in x-ray imaging of the distal end.No camera wire damage was observed in the pebax region of the catheter.X-ray imaging of the handle showed no problems with the breakout region or camera wires around the strain relief.X-ray imaging shows no damage to the camera wires at the printed circuit board assembly (pcba).The handle was opened and the electrical components inside were inspected visually.There was procedural residue seen in the plastic optic fibers (pof).Visual assessment showed no problems with the glue feature.The bond of the glue feature to the pcba was inspected; tweezers were used to wiggle the glue feature.The connection of the camera wires to the pcba was also inspected by slightly lifting the bottom of the glue feature for each of the four camera wires using the tip of the tweezers.No impact to image was seen after these interactions.A saline test was conducted, based on procedural residue found on the pofs, and after enough saline was inserted to reach the handle, there was no change to image.The handle was positioned vertically, and saline was inserted again, but still no change to image was observed.A live image was present throughout the saline test and the device functioned properly throughout analysis.The reported event was not confirmed.During product analysis, signs of use in the form of witness marks and procedural residue at the pofs were noted.A live image was seen upon insertion of the device and after conducting a saline test, there were no changes to the live image.The device functioned properly throughout testing and no defects were noted.Per medical review, the exact severity of patient condition reported in the complaint is unknown as additional information was not provided.Good faith efforts for additional information did not specify the cause of patient harms or relation of these harms to the complaint device itself.It is unclear if the patient condition worsened as a result of the observed failure of the device during procedure and analysis findings of the suspected complaint device could not determine an issue with the device itself.Therefore, based on all gathered information and related records, the probable cause selected for the reported event is cause not established, which indicates that investigation findings do not lead to a clear conclusion about the cause of the reported event and patient effects.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.The ifu does not explicitly list the adverse patient events reported in the complaint: injury nos, intubation, medication required, or surgical intervention.However, as per medical review, it is not clear that the device itself is attributed to the reported patient events.The reported severity of the patient events is unclear as well and the event will be reassessed upon further information or clarification.

Event Description

Note: note: this report pertains to the spyscope ds ii access & delivery catheter and spyglass ds controller used during the same procedure.Refer to manufacturer report#: 3005099803-2022-07963 for the spyscope ds ii access & delivery catheter and 3005099803-2023-00001 for the spyglass ds controller.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass ds controller were used during a cholangiopancreatography examination procedure performed on (b)(6) 2022.During the procedure, the spyscope ds ii did not work.They made several attempts; however, it was unsuccessful.Another technique was performed during the examination which was guided by rx device.It was reported that the patient's health condition was severe that required life-sustaining intervention.Vasoactive medications were given, orotracheal intubation and surgical intervention was performed by the physician.No further information has been obtained despite good faith efforts.

• 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: 16199691
• MDR Text Key: 307660454
• Report Number: 3005099803-2022-07963
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K183636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

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: 03/23/2023
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0027016154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other