MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO CL; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	M0068311350
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a capio cl device was used during a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the dart detached from the suture inside the patient.A second capio suture was opened and the dart did not deploy and it also detached from the suture.Reportedly, an x-ray was performed and the dart could not be located inside the patient.Therefore, it was concluded that the darts were still stuck in the device.The procedure was completed with another capio cl device.There were no patient complications reported as a result of this event.

• Brand Name: CAPIO CL
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8843880
• Report Number: 3005099803-2019-03729
• Device Sequence Number: 1658585
• Product Code: GCJ
• UDI-Device Identifier: 08714729516545
• UDI-Public: 08714729516545
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K973415
• 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): 07/30/2019

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: 04/12/2022
• Device Model Number: M0068311350
• Device Catalogue Number: 831-135
• Device Lot Number: 0023640358
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1