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

Model Number M00546610

Device Problems Optical Problem (3001); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The exact date of the event is unknown.The provided event date (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Initial reporter address 1: (b)(6).(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii was used during a cholangioscopy procedure in the biliary tree.According to the complainant, during the procedure, the image of the spyscope ds ii was lost.Reportedly, the patient had to undergo emergency surgery the same day due to the failure of the spyscope ds ii.The initial procedure (lithotripsy by choledoscopy) has been canceled due to this event.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii was used during a cholangioscopy procedure in the biliary tree.According to the complainant, during the procedure, the image of the spyscope ds ii was lost.Reportedly, the patient had to undergo emergency surgery the same day due to the failure of the spyscope ds ii.The intial procedure (lithotripsy by choledoscopy) has been canceled due to this event.There were no patient complications reported as a result of this event.***additional information received on(b)(6), 2020*** reportedly, the reason for surgery was the stone extraction (choledocholithiasis).

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 b3 (date of event): the exact date of the event is unknown.The provided event date (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block e1 (initial reporter address 1): (b)(6) block h6 (device codes): problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h6 (evaluation conclusion codes): conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr 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: 10233502
• MDR Text Key: 197987326
• Report Number: 3005099803-2020-02562
• 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: 08/10/2020

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 Model Number: M00546610
• Device Catalogue Number: 1759-02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention