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

Model Number M00568381

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2020 as no event date was reported.(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 a endovive standard peg kit pull method was unpacked on an unknown date.According to the complainant, there is a splinter inside the sterile packaging.Reportedly, this device was not used in the patient or procedure.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a endovive standard peg kit pull method was unpacked on an unknown date.According to the complainant, there is a splinter inside the sterile packaging.Reportedly, this device was not used in the patient or procedure.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block b3 (date of event): date of event was approximated to (b)(6) 2020 as no event date was reported.Block h6 (device codes): problem code 2969 captures the reportable event of foreign matter inside packaging.Block h10: an endovive standard peg kit was returned.Visual analysis revealed that the kit returned was unackaged and foreign material was inside the package.The reported complaint was confirmed.Based on the condition of the returned device, engineers determined that the failure mode observed is related to quality control deficiency.Boston scientific has determined the most probable cause of this complaint is quality control deficiency since it was traced to the failure to maintain or establish techniques for controlling and verifying the product specifications (including materials used) identified by the manufacture.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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
• MDR Report Key: 10755086
• MDR Text Key: 213661657
• Report Number: 3005099803-2020-04903
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K031538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: M00568381
• Device Catalogue Number: 6838
• Device Lot Number: 0024362838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1