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 Date 01/09/2017

Event Type  Injury  

Manufacturer Narrative

The device has been received for analysis.Upon 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 Description

Note: this report pertains to the third of three capio slim devices used during the same procedure.Associated mfr.Report #'s 3005099803-2017-00465 and 3005099803-2017-00466 pertain to the other two devices.It was reported to boston scientific corporation that a capio slim device was used during a sacrospinous ligament (ssl) apical suspension procedure.According to the complainant, during the procedure, after attempting to deploy the needle, the needle could not be retracted.When the device was removed, the springy needle holding area was detached from the device.The same event happened with the two more capio slim devices used.With the third device, they applied pressure and pulled the device.When the device was removed from the patient, the needle passer was missing and was confirmed to have remained inside the patient through a pelvic x-ray.The procedure was completed with another capio slim without further incident.All other information is unknown.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

A visual examination of the returned capio slim revealed that the carrier detached, and the carrier section was not returned by the customer.The device has the nitinol wire marks of crimping process.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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Based on the condition of the returned device and the evaluation conducted, a definitive root cause for the reported failure could not be determined; therefore, the root cause classification is undeterminable.The review and analysis of all available information fails to indicate a root cause or probable root cause for the reported event.

Event Description

Note: this report pertains to the second of three capio slim devices used during the same procedure.Associated mfr.Report numbers 3005099803-2017-00465 and 3005099803-2017-00467 pertain to the other two devices.It was reported to boston scientific corporation that a capio slim device was used during a sacrospinous ligament (ssl) apical suspension procedure.According to the complainant, during the procedure, after attempting to deploy the needle, the needle could not be retracted.When the device was removed, the springy needle holding area was detached from the device.The same event happened with the two more capio slim devices used.With the third device, they applied pressure and pulled the device.When the device was removed from the patient, the needle passer was missing and was confirmed to have remained inside the patient through a pelvic x-ray.The procedure was completed with another capio slim without further incident.All other information is unknown.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on march 2, 2017: procedure happened on (b)(6) 2017.Patient's condition was good.

• 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 ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6385329
• MDR Text Key: 69287707
• Report Number: 3005099803-2017-00467
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729842224
• UDI-Public: (01)08714729842224(17)20190414(10)19138104
• Combination Product (y/n): N
• 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,Followup
• Report Date: 02/09/2017

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: 04/14/2019
• Device Model Number: M0068318261
• Device Catalogue Number: 831-826
• Device Lot Number: 19138104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 03/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2016
• 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
• Patient Age: 80 YR