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

Model Number M00546550

Device Problems Entrapment of Device (1212); Difficult to Open or Close (2921); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon 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 spyglass retrieval basket was used during an endoscopic retrograde cholangiopancreatography (ercp) with electrohydraulic lithotripsy (ehl) procedure performed in the cystic duct on (b)(6) 2020.According to the complainant, during the procedure, the spybasket was passed to retrieve stone fragments; however, the basket became impacted in the cystic duct.They tried to open and close basket; however, it would not move.They cut the catheter of basket below the handle so that they could remove the spybasket; however, the basket catheter got stuck in the working channel of the spyscope ds ii.Ultimately they had to cut the spyscpoe ds ii catheter below the handle to remove duodenoscope.The spyscope ds ii was successfully removed.The basket was still impacted in the patient.Reportedly, the patient was stented and rescheduled for a follow up procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (device codes): problem code 2921 captures the reportable event of basket failure to release stone.Problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned spybasket was analyzed, and a visual evaluation noted that the handle was separated from the sheath.The handle cap and the basket-wire assembly were not returned.The sheath was kinked in several locations, also it was torn at distal section.The wire in the handle was checked under magnification and the mark observed in the wire is consistent with one caused by compression by a mechanical tool.The reported complaint was not confirmed.It is most likely that the damages observed in the device were caused due to handling and manipulation of the device during procedure.Also, the process to cut the device to remove it from the patient could have kinked and torn the sheath.The directions for use (dfu) states as a warning "to avoid basket impaction, use fluoroscopy or x-ray and direct visualization to determine the size of the stone or foreign body.Do not use basket if stone or foreign body cannot be removed endoscopically or held in the basket.In the unlikely event of basket impaction, use wire cutting pliers to cut the sheath below the distal end of the handle to remove the spyglass delivery system from the device." additionally, the dfu mentions basket impaction as a possible complication that may result from an ercp procedure.Based on all gathered information the most probable root cause is known inherent risk of device due to the reported adverse event known and documented in the labeling (including both short or long term known complications or adverse reactions).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 during an endoscopic retrograde cholangiopancreatography (ercp) with electrohydraulic lithotripsy (ehl) procedure performed in the cystic duct on (b)(6)2020.According to the complainant, during the procedure, the spybasket was passed to retrieve stone fragments; however, the basket became impacted in the cystic duct.They tried to open and close basket; however, it would not move.They cut the catheter of basket below the handle so that they could remove the spybasket; however, the basket catheter got stuck in the working channel of the spyscope ds ii.Ultimately they had to cut the spyscpoe ds ii catheter below the handle to remove duodenoscope.The spyscope ds ii was successfully removed.The basket was still impacted in the patient.Reportedly, the patient was stented and rescheduled for a follow up procedure.There were no patient complications reported as a result of this event.

• 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: 10426845
• MDR Text Key: 203685598
• Report Number: 3005099803-2020-03439
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2021
• Device Model Number: M00546550
• Device Catalogue Number: 4655
• Device Lot Number: 0024474794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1