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

Model Number M00568390

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

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

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 an endovive standard peg kit pull method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2021.During the procedure, the physician stated that the peg tube was too soft, not holding the gastric wall and the wire at the tip of tube broke.Consequently, the peg tube was pulled out of the patient during the initial placement.The procedure was completed a new endovive standard peg kit pull method.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (device codes): device code a0501 captures the reportable event of peg tube detached.Device code a051201 captures the reportable event of peg tube dislodged.Block h10: an endovive standard pull peg tube was returned.Visual analysis revealed that the pull wire at the tip was detached and the tube presented stretch marks.Under microscope, an evidence of tension at the pull wire tip was noted.The reported complaint was confirmed.Based on the condition of the returned device, engineers determined that the failure mode observed it is most likely that the user during the procedure applied some technique or some manipulation that ended providing an extra tension to the device which lead the detachment.As consequence, the peg tube become dislodged.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on event which led to the reported event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that an endovive standard peg kit pull method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6)2021.During the procedure, the physician stated that the peg tube was too soft, not holding the gastric wall and the wire at the tip of tube broke.Consequently, the peg tube was pulled out of the patient during the initial placement.The procedure was completed a new endovive standard peg kit pull method.There were no patient complications reported as a result of this event.

• 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: 12688716
• MDR Text Key: 278109871
• Report Number: 3005099803-2021-05436
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): Y
• Reporter Country Code: SF
• PMA/PMN Number: K031538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• 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: 0027616795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2021
• 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