MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ENDOVIVE¿ ONE STEP BUTTON¿; TUBE, GASTRO-ENTEROSTOMY

Model Number M00568510

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).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

It was reported to boston scientific corporation that a one step button initial placement gastrostomy kit was used during a gastrostomy procedure.The procedure date is unknown.According to the complainant, during procedure, the tube was detached after being pulled from the stomach.The procedure was completed with a different device.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

A visual examination of the returned device found the suture and the red strip had remained attached to the returned product, moreover the c flex tube was found to be broken at 0.5 mm from the connector, the rest of the device was not present and not returned for analysis.It was noted that the condition of the returned unit was consistent with the complaint incident that the button tube became separated.It is the most likely that during the procedure the device could have been damaged since the failure found (c flex tube broken), is an issue that could have been generated by excessive manipulation of the device by the user, the interaction with the scope or the interacting with other device.Since it is most likely that due to anatomical and/or procedural factors encountered during the procedure, performance was limited.Therefore the most probable root cause of this complaint is ¿operational context¿.

Event Description

It was reported to boston scientific corporation that a one step button initial placement gastrostomy kit was used during a gastrostomy procedure.The procedure date is unknown.According to the complainant, during procedure, the tube was detached after being pulled from the stomach.The procedure was completed with a different device.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: ENDOVIVE¿ ONE STEP BUTTON¿
• Type of Device: TUBE, GASTRO-ENTEROSTOMY
• 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: 6901074
• MDR Text Key: 87644553
• Report Number: 3005099803-2017-02947
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• PMA/PMN Number: K910584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2017

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
• Device Operator: Health Professional
• Device Model Number: M00568510
• Device Catalogue Number: 6851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 10/12/2017
• Supplement Dates FDA Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1