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

Model Number M00568390

Device Problems Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2023

Event Type  malfunction  

Manufacturer Narrative

E1: this event was reported by the sales representative.The healthcare facility is: (b)(6).H6 (device codes): imdrf device code a180104 captures the reportable event of foreign material present in device.

Event Description

It was reported to boston scientific corporation that an endovive standard peg kit pull method was used during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2023.It was reported that, a mold was found within the sterile packaging of the peg tube.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block e1: this event was reported by the sales representative.The healthcare facility is: (b)(6) hospital block h6 (device codes): imdrf device code a1802 captures the reportable event of foreign material present in the packaging.Block h11 (correction): f10 (device codes), h6 (device codes) have been updated.

Event Description

It was reported to boston scientific corporation that an endovive standard peg kit pull method was used during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2023.It was reported that, a mold was found within the sterile packaging of the peg tube.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• Brand Name: ENDOVIVE STANDARD 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: 18536147
• MDR Text Key: 333372955
• Report Number: 3005099803-2024-00070
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K031538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00568390
• Device Catalogue Number: 6839S
• Device Lot Number: 0031605819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2023
• 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