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

Model Number M00546610

Device Problems Poor Quality Image (1408); Material Integrity Problem (2978); Optical Problem (3001); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

(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

Note: this report pertains to the second of two spyscope ds ii used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii was used in the common bile duct during a cholangioscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noticed that after flushing the common bile duct the image of the spyscope ds ii flickered and was lost approximately 45 minutes into the procedure.A second spyscope ds ii was used; however, the image also flickered and was lost approximately 30 minutes later.Reportedly, a seal leakage at the distal part was noted on the two spyscope ds ii devices.The procedure was not completed due to this event and will be rescheduled for (b)(6) 2020.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 ok.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii was used in the common bile duct during a cholangioscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noticed that after flushing the common bile duct the image of the spyscope ds ii flickered and was lost approximately 45 minutes into the procedure.A second spyscope ds ii was used, however, the image also flickered and was lost approximately 30 minutes later.Reportedly, a seal leakage at the distal part was noted on the two spyscope ds ii devices.The procedure was not completed due to this event and will be rescheduled for (b)(6) 2020.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 ok.

Manufacturer Narrative

Block h6 (device codes): problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned spyscope ds ii was analyzed, and a visual evaluation noted that there were no elevator marks on the shaft of the catheter.No 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.No image was displayed.Real-time x-ray was used to image the distal tip, including the camera and wires.The x-ray showed a camera wire appearing damaged at the camera housing/cap.In the handle, no damage was observed to the printed circuit board (pcb).It was noted that the wires or through-silicon vias tsvs appeared to have residue present, possibly from fluid ingress or corrosion.It is possible that fluid reached the redistribution layer (rdl) or tsv and as it dried, electrical properties of the connection point changed and resulted in the failure of the device.The handle was opened and the camera wire and glue feature at the solder pad was inspected.It appeared that the ground and power wires were exposed through the glue feature.The solder pad and resistor on the printed circuit board assembly (pcba) were mechanically exposed.Using a multimeter the continuity and resistance of the ground connection was checked.It was confirmed that the wire was electrically exposed through the glue; however no increased resistance was noted.No evidence of fluid was noted inside the handle.The reported event was confirmed.The condition of the wires suggests a lack of controls regarding camera wire handling during the manufacturing process (likely during camera/pof potting, stuffing, and/or pof bonding), resulting in nicked insulation of the camera wires.It is likely that the damage to the camera wire, as well as exposure to saline and/or procedural fluids, shorted out the camera during the procedure, causing the reported visualization issue and introducing potential corrosion.An investigation was completed to address visualization issues due to camera wire damage.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 10303561
• MDR Text Key: 199887822
• Report Number: 3005099803-2020-02902
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• PMA/PMN Number: K142922
• 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: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: M00546610
• Device Catalogue Number: 1759-02
• Device Lot Number: 25286429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1