MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYBITE; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M00546270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Perforation (2001)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.(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 or Problem Description
Note: this report pertains to a spyscope ds ii, spybite, and jagwire used during the same procedure.Refer to manufacturer report # 3005099803-2020-00067 and 3005099803-2020-00068 for the other associated device information.It was reported to boston scientific corporation that a spyscope ds ii, spybite, jagwire revolution and a non-bsc sphincterotome were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) and cholangioscopy procedure performed on (b)(6) 2019.According to the complainant, after the procedure, the patient suffered an air embolism which was suspected to be caused by a perforation.The physician could not confirm if the perforation was related to the spyscope, spybite, guidewire, or non-bsc sphincterotome.Boston scientific has been unable to obtain additional information regarding the cause of the perforation to date, despite good faith efforts.

• Brand Name: SPYBITE
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9595706
• Report Number: 3005099803-2020-00069
• Device Sequence Number: 428522
• Product Code: FCL
• UDI-Device Identifier: 08714729764458
• UDI-Public: 08714729764458
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00546270
• Device Catalogue Number: 4627
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention