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)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The complaint device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a capio packaged, pc device was used during an anterior and posterior repair with acell, sphincter repair using acell cytal wound matrix 6-layer mesh procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the physician experienced difficulty with catching the dart in the cage.Reportedly, he loaded and deployed the suture a few times before the suture was passed through the ligament.It was believed that this was due to not thoroughly rinsing the capio device in between throws into the ligament.Subsequently, the dart detached from the suture on the patient's right side and was not retrieved.There was no any attempt to remove the dart from the patient.The physician believed that the dart might have detached from the suture after deployment, while the device was being pulled from the sacrospinous ligament.The procedure was completed with another capio device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation that a capio packaged, pc device was used during an anterior and posterior repair with acell, sphincter repair using acell cytal wound matrix 6-layer mesh procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the physician experienced difficulty with catching the dart in the cage.Reportedly, he loaded and deployed the suture a few times before the suture was passed through the ligament.It was believed that this was due to not thoroughly rinsing the capio device in between throws into the ligament.Subsequently, the dart detached from the suture on the patient's right side and was not retrieved.There was no any attempt to remove the dart from the patient.The physician believed that the dart might have detached from the suture after deployment, while the device was being pulled from the sacrospinous ligament.The procedure was completed with another capio device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.Additional information received on august 18, 2020: approximately 3mm dart detached from the suture and was unable to visualize on x-ray.
Additional Manufacturer Narrative
Additional information: block e1: additional contact: (b)(6).Block h6: device code 2907 captures the reportable event of the suture dart detachment.Block h10: the complaint device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Block h10: the voluntary user medwatch number is mw5094416.

• 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: 10112106
• Report Number: 3005099803-2020-02011
• Device Sequence Number: 14314781
• Product Code: GCJ
• UDI-Device Identifier: 08714729257622
• UDI-Public: 08714729257622
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K932553
• 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,Followup
• Report Date (Section B): 09/16/2020

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: M0068312321
• Device Catalogue Number: 831-232
• Device Lot Number: 0024413962
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1