MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) 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	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.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 one of two devices used during the same procedure.Refer to manufacturer report# 3005099803-2018-01800 for the spyscope digital access and delivery catheter, and 3005099803-2018-01801 for the spybite¿ biopsy forceps.It was reported to boston scientific corporation that a spyscope digital access & delivery catheter and a spybite¿ were used in the common bile duct (cbd) during a bile duct biopsy procedure performed on (b)(6) 2018.According to the complainant, they performed bile duct biopsy using these devices.On (b)(6) 2018, an endoscopy confirmed that the patient was bleeding and afterwards the patient experienced severe pain.A non-bsc covered stent was used to stop the bleeding but it perforated the bile duct, and part of the stent protruded into the abdominal cavity.The bleeding was not stopped.They used a hardener and a metal coil during angiography and the bleeding was stopped.The stent remained inside the patient and an endoscopic removal procedure is planned.In the physician's assessment, the patient had liver cirrhosis and then during use, the devices scrubbed the bile duct near duodenal papilla.Aneurysm had developed and bleeding occurred.There were no reported malfunction of the spyscope ds and spybite¿.The patient's condition after this procedure was reported to be stable.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report# 3005099803-2018-01800 for the spyscope digital access.It was reported to boston scientific corporation that a spyscope digital access & delivery catheter and a spybite¿ were used in the common bile duct (cbd) during a bile duct biopsy procedure performed (b)(6) 2018.According to the complainant, they performed bile duct biopsy using these devices.On may 1, 2018, an endoscopy confirmed that the patient was bleeding and afterwards the patient experienced severe pain.A non-bsc covered stent was used to stop the bleeding but it perforated the bile duct, and part of the stent protruded into the abdominal cavity.The bleeding was not stopped.They used a hardener and a metal coil during angiography and the bleeding was stopped.The stent remained inside the patient and an endoscopic removal procedure is planned.In the physician's assessment, the patient had liver cirrhosis and then during use, the devices scrubbed the bile duct near duodenal papilla.Aneurysm had developed and bleeding occurred.There were no reported malfunction of the spyscope ds and spybite¿.The patient's condition after this procedure was reported to be stable.Additional information received on june 4, 2018.The location of the bleeding was reported to be in the bile duct, which was related to the location of the perforation.It is unknown if the patient was on anticoagulants, however, it was reported that the patient has a tendency to bleed easily because the patient has liver cirrhosis.There were no reported defects of the spyscope ds that may have contributed to the event.

• Brand Name: SPYBITE¿
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7548686
• Report Number: 3005099803-2018-01801
• Device Sequence Number: 11187091
• Product Code: FCL
• UDI-Device Identifier: 08714729764458
• UDI-Public: 08714729764458
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

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
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1