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 12/06/2017

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(6).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 Description

Note:this report pertains to one of two devices used during the same procedure.Associated mfr report #3005099803-2017-03847 pertains to the other device.It was reported to boston scientific corporation that a suture capturing device was used during a sacrospinous fixation procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the capio carrier (the hook on the end of the capio) broke off and the needle detached and fell into the patient.Reportedly, the physician had to open the patient abdominally to locate the needle.However, due to the position of the needle, the physician was unable to retrieve it from the patient.It was reported that the needle was visible on x-ray.The procedure was not completed due to another reason.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Lot number is either 20552145 or 20417300.Both reported lot numbers match upn (b)(4).Lot 20552145 has manufacture date 04/22/2017 and expiration date 04/20/2020.Lot 20417300 has manufacture date 03/20/2017 and expiration date 03/17/2020.

Event Description

Note:this report pertains to one of two devices used during the same procedure.Associated mfr report #3005099803-2017-03847 pertains to the other device.It was reported to boston scientific corporation that a suture capturing device was used during a sacrospinous fixation procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the capio carrier (the hook on the end of the capio) broke off and the needle detached and fell into the patient.Reportedly, the physician had to open the patient abdominally to locate the needle.However, due to the position of the needle, the physician was unable to retrieve it from the patient.It was reported that the needle was visible on x-ray.The procedure was not completed due to another reason.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on january 3, 2018.During the procedure, only one capio device malfunctioned.The carrier broke off inside the patient and was not retrieved despite several attempts to remove it.The patient is recovering well and is coming back at the end of (b)(6) for a repeat x-ray examination.The patient will again undergo an x-ray examination after six months and then annually to monitor the location of the detached capio carrier.In addition, the capio cage also detached from the housing on one end.A second capio device was opened to finish the procedure.

Manufacturer Narrative

A visual examination of the returned capio¿ slim revealed that the cage was damaged and the carrier was broken.The broken section of the carrier was not returned.Due to the condition of the device, a functional examination was not performed.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

This report pertains to one of two devices used during the same procedure.Associated mfr report #3005099803-2017-03847 pertains to the other device.It was reported to boston scientific corporation that a suture capturing device was used during a sacrospinous fixation procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the capio carrier (the hook on the end of the capio) broke off and the needle detached and fell into the patient.Reportedly, the physician had to open the patient abdominally to locate the needle.However, due to the position of the needle, the physician was unable to retrieve it from the patient.It was reported that the needle was visible on x-ray.The procedure was not completed due to another reason.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on january 3, 2018.During the procedure, only one capio device malfunctioned.The carrier broke off inside the patient and was not retrieved despite several attempts to remove it.The patient is recovering well and is coming back at the end of (b)(6) for a repeat x-ray examination.The patient will again undergo an x-ray examination after six months and then annually to monitor the location of the detached capio carrier.In addition, the capio cage also detached from the housing on one end.A second capio device was opened to finish the procedure.

• 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: 7164774
• MDR Text Key: 96385588
• Report Number: 3005099803-2017-03850
• Device Sequence Number: 1
• Product Code: FHQ
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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,Followup
• Report Date: 12/06/2017

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: 04/20/2020
• Device Model Number: M0068318261
• Device Catalogue Number: 831-826
• Device Lot Number: 20552145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 01/03/2018; 04/05/2018
• Supplement Dates FDA Received: 01/31/2018; 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2017
• 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): Required Intervention