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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS II ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS II ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number M00546610
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/10/2020
Event Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).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 spyscope ds ii access & delivery catheter was used during cholangioscopy procedure in the bile duct performed on (b)(6) 2020.According to the complainant, during the procedure, it was noticed that the distal tip of the spyscope ds ii detached.Reportedly, the detached part was successfully retrieved.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Additional information: b5 block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6 (device codes): problem code 2907 captures the reportable event of detached catheter component.Block h6 (evaluation conclusion codes): conclusion code 4316 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.
 
Event Description
It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used during cholangioscopy procedure in the bile duct performed on (b0(6), 2020.According to the complainant, during the procedure, it was noticed that the distal tip of the spyscope ds ii detached.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.*additional information received on (b)(6), 2020* reportedly, "foreign material appeared in the bile duct." this was confirmed to be part of the spyscope ds ii.Additionally, the detached part of the spyscope ds ii was not retrieved as the papillotomy was big enough that the part could just fall out through the papilla by bile flow.
 
Manufacturer Narrative
Correction - block d4 (catalog number): corrected from 1759-02 to 4661.Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6 (device codes): problem code 2907 captures the reportable event of detached catheter component.Block h10: the returned spyscope ds ii was analyzed, and a visual evaluation was performed.No elevator marks were noted along the shaft.No additional damage was noted.Witness marks were observed on the contacts of the umbilicus connector, indicating it was connected to a controller.An image assessment was performed.The device was plugged into the controller.A live, clear image was displayed.Real-time x-ray was used to image the distal tip, including the camera and wires.The x-ray showed no camera wire damage at the camera on the distal tip.In the handle, no damage was observed to the printed circuit board assembly (pcba).The camera wire was noted as suspicious in the breakout region.The handle was opened and the components within were visually inspected.No issues were noted with the internal components.The reported event was not confirmed.Upon analysis, there were no issues identified with the returned device.Catheter tearing is a failure mode that is accounted for in the design, and is mitigated by material specification of the shaft, braid, and tip; therefore, it is unlikely that the event was due to material defect.Interaction with the duodenoscope elevator during the procedure can damage the catheter, as handling of these devices in tortuous anatomy may result in more forces applied to the shaft of the catheter.Based on all gathered information, the most probable root cause of this complaint is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
 
Event Description
It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used during cholangioscopy procedure in the bile duct performed on (b)(6) 2020.According to the complainant, during the procedure, it was noticed that the distal tip of the spyscope ds ii detached.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.*additional information received on september 3, 2020* reportedly, "foreign material appeared in the bile duct." this was confirmed to be part of the spyscope ds ii.Additionally, the detached part of the spyscope ds ii was not retrieved as the papillotomy was big enough that the part could just fall out through the papilla by bile flow.
 
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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 Key10487679
MDR Text Key205480816
Report Number3005099803-2020-03707
Device Sequence Number1
Product Code FBN
UDI-Device Identifier08714729965404
UDI-Public08714729965404
Combination Product (y/n)N
PMA/PMN Number
K142922
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/21/2020
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? Yes
Device Operator Health Professional
Device Expiration Date07/10/2022
Device Model NumberM00546610
Device Catalogue Number4661
Device Lot Number0025697786
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Initial Date Manufacturer Received 08/14/2020
Initial Date FDA Received09/03/2020
Supplement Dates Manufacturer Received09/03/2020
09/29/2020
Supplement Dates FDA Received09/25/2020
10/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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