MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SAFETY PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number UNK-M-57690

Device Problem Difficult to Advance (2920)

Patient Problem Pain (1994)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2018 as no event date was reported.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown at this time.(b)(4).The complainant indicated that the device will not be returned for evaluation as it is implanted in the patient; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during a percutaneous endoscopic gastrostomy procedure.The exact procedure date was unknown; however it was reported that it was placed a week before the event happened.According to the complainant, the patient went to the emergency room due to pain at the peg site.Patient also complained of leaking around the tube and the external bolster was tight against the skin.Ct scan was ordered and revealed that there was inflammation of the fat between the stomach and the skin.There was tenting of the gastric mucosa.The boston peg tube external bolster was extremely difficult to loosen, wherein it stretched the peg tube when trying to loosen the external bolster.They used two clamps, one of which was grasping the tube between the skin and the other clamp was used to grasp the external bolster which induced pain to the patient.

• Brand Name: ENDOVIVE SAFETY PEG KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8125840
• MDR Text Key: 129084634
• Report Number: 3005099803-2018-61705
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2018

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: UNK-M-57690
• Device Catalogue Number: 57690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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