MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO ; HOLDER, NEEDLE, GASTROENTEROLOGIC

Model Number	STANDARD
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Boston scientific capio device and associated suture malfunctioned, causing the "bullet" to break and a small piece (approx 3 mm) broke off.Unable to visualize on xray.Fda safety report id# (b)(4).

• Brand Name: CAPIO
• Common Device Name: HOLDER, NEEDLE, GASTROENTEROLOGIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 10038259
• Report Number: MW5094416
• Device Sequence Number: 2851114
• Product Code: FHQ
• UDI-Device Identifier: 08714729753087
• UDI-Public: 08714729753087
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2022
• Device Model Number: STANDARD
• Device Catalogue Number: M0068312320
• Device Lot Number: 24413962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2020
• 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: Hospitalization
• Patient Age: 48 YR
• Patient Weight: 60