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

Model Number M00546610

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Pneumothorax (2012); Unspecified Respiratory Problem (4464)

Event Date 12/15/2022

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Patient codes: (b)(4).

Event Description

Note: this report pertains to a spyscope ds ii access & delivery catheter and a dreamtome used in the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and a dreamtome were used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2022.At the night of the procedure, the patient had perforation and a collapsed lung.There was no intervention performed to address the perforation.The physician did not think that the spyscope ds ii and the dreamtome with the guidewire caused the perforation.The physician believed that the perforation was due to "the ampulla in a tic." additionally, there was no device malfunction with the spyscope ds ii, the dreamtome and the guidewire.The procedure was completed using an extractor balloon, and a large stone was removed.The patient's condition at the conclusion of the procedure was reported to be "ok.".

Event Description

Note: this report pertains to a spyscope ds ii access & delivery catheter and a dreamtome used in the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and a dreamtome were used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2022.At the night of the procedure, the patient had perforation and a collapsed lung.There was no intervention performed to address the perforation.The physician did not think that the spyscope ds ii and the dreamtome with the guidewire caused the perforation.The physician believed that the perforation was due to "the ampulla in a tic." additionally, there was no device malfunction with the spyscope ds ii, the dreamtome and the guidewire.The procedure was completed using an extractor balloon, and a large stone was removed.The patient's condition at the conclusion of the procedure was reported to be "ok".Additional information received on january 12, 2023: it was reported that the perforation was discovered through imaging; however, the imaging type was unknown.Additionally, the guidewire being used during the procedure was a preloaded guidewire of the dreamtome.

Manufacturer Narrative

Block h2 (additional information): block b5 has been updated based on the additional information received on january 12, 2023.Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block h6: patient code e2114 captures the reportable event of perforation.Patient code e0734 captures the reportable event of pneumothorax.Block h11 (correction): block h6 (patient codes) and block h10 have been corrected.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16113060
• MDR Text Key: 306809168
• Report Number: 3005099803-2022-07985
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Male