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

Model Number	M00546470
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf patient code e0602 captures the reportable event of cardiac arrest.Imdrf impact code f2306 captures the reportable event of cardiopulmonary resuscitation.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-03260 for the spyscope ds ii access & delivery catheter and 3005099803-2024-03292 for the spybite biopsy forcep.It was reported to boston scientific corporation that a spybite max biopsy forceps was used during an endoscopic retrograde cholangiopancreatopography (ercp) procedure in the common bile duct for the treatment of ercp stricture on (b)(6) 2024.During the procedure, the physician used a tome and wire to access the site.Once the site was accessed, they noticed that they could not get through the bifurcation.The physician introduced the spyscope to get a better visual and observed what looked like a malignant wall.Bubbles were suctioned out via syringe to clear the view.They then inserted a spybite biopsy forcep down the scopes channel.After some difficulty getting the spybite through the curved position of the scope, they cannulated and took a biopsy.The forceps were then removed and inserted again to obtain another biopsy.The patient began to crash, the scope was removed, and a code blue was called.Cardiopulmonary resuscitation (cpr) was performed on the patient.There is no allegation against the performance of the spybite or spyscope used in this case.The patient's current condition is reported to be normal.

• Brand Name: SPYBITE MAX
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19735367
• Report Number: 3005099803-2024-03292
• Device Sequence Number: 15456008
• Product Code: FCL
• UDI-Device Identifier: 08714729996699
• UDI-Public: 08714729996699
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2024

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: M00546470
• Device Catalogue Number: 4647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 07/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown