MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CAPIO¿ SLIM; HOLDER, NEEDLE, GASTROENTEROLOGIC

Model Number M0068318261

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

(b)(4).A visual examination of the returned capio¿ slim revealed several damages in the distal section, the head halves come apart however there is evidence that the riveting process was done correctly.Also, the cage returned broke in two sections, this failures is evidence of excess of force applied to the tip.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.The investigation concluded that this complaint is associated with a product that meets the design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.The most probable root cause classification is operational context.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that a capio slim was used during a sacrospinous ligament fixation procedure performed on an unknown date.According to the complainant, during the procedure, the head of the capio slim device split in half.The needle detached from the suture and was left inside the patient.The procedure was completed with another capio slim.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: CAPIO¿ SLIM
• Type of Device: HOLDER, NEEDLE, GASTROENTEROLOGIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 2546 first street; propark free zone; alajuela ; CS ; 5062436800
• MDR Report Key: 6720614
• MDR Text Key: 80246761
• Report Number: 3005099803-2017-02116
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729842224
• UDI-Public: (01)08714729842224(17)20200322(10)20440679
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2020
• Device Model Number: M0068318261
• Device Catalogue Number: 831-826
• Device Lot Number: 20440679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2017
• Initial Date FDA Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other