MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS RETRIEVAL BASKET; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number M00546550

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2020

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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a spyglass retrieval basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noticed that the handle broke after several attempts to open the spybasket.Reportedly, prior to placement inside the patient, the device could open and close.Reportedly, the physician also attempted to use non bsc baskets for stone removal.However, the procedure was not completed due to this event.The procedure was rescheduled.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 good.

Manufacturer Narrative

Block h6 (device codes): problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: visual examination of the returned device revealed that the handle was not broken and the basket was in a closed position when received.The cannula inside the handle was found kinked and detached.Additionally, the distal section of the working length was found slightly kinked.A functional assessment was not performed due to the device condition (cannula inside the handle detached).The complaint was not consistent with the reported event of spybasket handle break; however, the handle cannula was completely detached from the handle, consequently confirming the complaint.It was determined that procedural factors encountered during procedure could have affected the device performance and its integrity.Handling and manipulation of the device during its use can lead to bent/kinked working length.Additionally, continued attempts to actuate the handle to open/close the basket could contribute to the encountered issue.This condition can result in stress between the components and cause detachment.Therefore, the most probable cause of this complaint is adverse event related to procedure.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 spyglass retrieval basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noticed that the handle broke after several attempts to open the spybasket.Reportedly, prior to placement inside the patient, the device could open and close.Reportedly, the physician also attempted to use non bsc baskets for stone removal.However, the procedure was not completed due to this event.The procedure was rescheduled.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 good.

• Brand Name: SPYGLASS RETRIEVAL BASKET
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10302279
• MDR Text Key: 199693641
• Report Number: 3005099803-2020-02878
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 08714729965886
• UDI-Public: 08714729965886
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2020
• Device Model Number: M00546550
• Device Catalogue Number: 4655
• Device Lot Number: 0022806198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1