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

Model Number	M0068318261
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The 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 slim device was used during a prolapse repair procedure performed on (b)(6), 2019.According to the complainant, during the procedure, when the physician deployed the capio suture on the patient's right side using the capio device, the dart detached and was left inside the patient.The dart was not removed from the patient because it could not be located by palpation.Reportedly, the suture was left free hanging during the deployment.The suture was deployed three times and there were no partials throws made.The procedure was completed with another capio slim device.There were no patient complications noted as a result of the event.The patient's condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
(b)(4).A capio device was returned for analysis.Residues of blood were observed on the device.No visual issues were observed with the catch and carrier.Also, the 10 riveting pins were in place.Functional analysis was performed by actuating the carrier three times and it could be extended and retracted without any issues.Also, it was actuated (deployed) three times with the suture and the dart entered in the catch slot without any issues.The dhr review was performed and no anomalies were observed, the review confirmed that the accepted device met all manufacturing specifications and boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.After analysis it was determined that the device did not present any visual issue and it worked as intended.It did not show evidence of either the alleged issue or any defect that could have contributed to the event reported.Therefore, the investigation concluded that the most probable cause for the reported issue is no problem detected, since the device complaint or problem cannot be confirmed.
Event or Problem Description
It was reported to boston scientific corporation that a capio slim device was used during a prolapse repair procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when the physician deployed the capio suture on the patient's right side using the capio device, the dart detached and was left inside the patient.The dart was not removed from the patient because it could not be located by palpation.Reportedly, the suture was left free hanging during the deployment.The suture was deployed three times and there were no partials throws made.The procedure was completed with another capio slim device.There were no patient complications noted as a result of the event.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: CAPIO SLIM
• Common Device Name: HOLDER, NEEDLE, GASTROENTEROLOGIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9188818
• Report Number: 3005099803-2019-04871
• Device Sequence Number: 2532457
• Product Code: FHQ
• UDI-Device Identifier: 08714729842224
• UDI-Public: 08714729842224
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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: 08/27/2021
• Device Model Number: M0068318261
• Device Catalogue Number: 831-826
• Device Lot Number: 0022576399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1