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

Model Number M00546600

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2017

Event Type  Injury  

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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, there was difficulty flushing water through the scope after inserting the scope into the bile duct.An ehl probe was advanced through the spyscope and when it exited the spyscope the ehl probe could not be seen.As the physician was removing the spyscope ds from the patient, the tip of the spyscope ds completely detached and dropped into the duodenum.It is unknown if attempts to retrieve the detached tip were made.The procedure was not completed.The patient's condition at the conclusion of the procedure was reported to be fine.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Visual examination of the spyscope ds device found that the outer ring of the distal cap was completely detached from the device when received; the cap was not returned for analysis.The catheter's steering ring, camera cable, pof's and working channel were exposed at the distal tip.The camera wire was bunched up proximal to the star tubing.The spyscope ds was not plugged into the controller due to the condition of the returned device.Since the camera detached with the distal cap, the device could not produce any live image.The device was flushed with water; the water exited from the distal tip of the working channel, which was exposed due to detached distal cap.There was evidence that heat was applied on the outside of the catheter during manufacturing assembly.Additionally, laser weld marks were also present on the outside and inside of the steering ring.There was no evidence to indicate the device was not properly manufactured.The complaint was consistent with the reported event of distal tip detached.Based on the investigation and the receipt condition/functionality, the most probable root cause is "manufacturing".An investigation has been initiated to address this issue.  a dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no other complaints exist for the specified batch.A labeling review was performed and there is no evidence that the device was not used in accordance with the labeling.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, there was difficulty flushing water through the scope after inserting the scope into the bile duct.An ehl probe was advanced through the spyscope and when it exited the spyscope the ehl probe could not be seen.As the physician was removing the spyscope ds from the patient, the tip of the spyscope ds completely detached and dropped into the duodenum.It is unknown if attempts to retrieve the detached tip were made.The procedure was not completed.The patient's condition at the conclusion of the procedure was reported to be fine.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: SPYSCOPE DS ACCESS & DELIVERY CATHETER
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6556253
• MDR Text Key: 74789054
• Report Number: 3005099803-2017-01375
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: (01)08714729863236(17)20190131(10)20219721
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

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 Date: 01/31/2019
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 20219721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 05/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention