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

Model Number	M0068312321
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact age of the patient is unknown.However, it was reported the patient was over 18 years.(b)(4).The complainant indicated that the device is disposed, and 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
Note: this manufacturer report pertains to the second of two devices used during the procedure.It was reported to boston scientific corporation that two capio packaged, pc devices were used during a sacrospinous ligament fixation performed on (b)(6) 2020 to treat prolapse.According to the complainant, during the procedure, the physician had a difficulty loading the suture into the carrier.Once the suture was loaded and the device was deployed on the patient's right side, the dart detached from the suture, but remained loose in the capio device.The dart did not fall off into the patient.A second device was opened, but the same issue occurred.The procedure was completed with another capio packaged, pc device.There were no patient complications reported as a result of the event.

• Brand Name: CAPIO
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10858608
• Report Number: 3005099803-2020-05289
• Device Sequence Number: 19573845
• Product Code: GCJ
• UDI-Device Identifier: 08714729257622
• UDI-Public: 08714729257622
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 11/17/2020

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: 07/30/2021
• Device Model Number: M0068312321
• Device Catalogue Number: 831-232
• Device Lot Number: 0022451385
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1