MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number UNK518

Device Problem Torn Material (3024)

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

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant stated that the device was used for 5 years.(b)(4).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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that an endovive initial placement peg kit was used during a percutaneous endoscopic gastrostomy procedure.The procedure date is unknown.According to the complainant, this information was obtained from a slide presentation done by a gastro surgeon, (b)(6).Reportedly,when the peg tube was removed from the patient in 2015, the tube was split/torn.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 INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7609174
• MDR Text Key: 111326565
• Report Number: 3005099803-2018-02040
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K150679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNK518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2018
• 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: N
• Patient Sequence Number: 1
• Treatment: DUODOPA