MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRATOME XL; SNARE, FLEXIBLE

Model Number M00535900

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 09/01/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event.(b)(4).

Event Description

It was reported to boston scientific corporation that an ultratome xl was viewed at the "time of the conference in the consigned sector".The exact event date was unknown.Upon checking the device, a hair was found inside the package.There was no procedure involved and the device was not used in the patient.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6 (device codes): medical device problem code a1802 captures the reportable event of foreign material present in the packaging of the device.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that a foreign material was inside the pouch, which was consistent with the findings when the pouch was observed under magnification.No other problems with the device were noted.The reported event of foreign material inside the package was confirmed.Upon analysis, it was found that a foreign material was found inside the pouch.Based on all gathered information, this complaint will be document as manufacturing deficiency.An investigation is in place to address this problem.

Event Description

It was reported to boston scientific corporation that an ultratome xl was viewed at the "time of the conference in the consigned sector".The exact event date was unknown.Upon checking the device, a hair was found inside the package.There was no procedure involved and the device was not used in the patient.No further information has been obtained despite good faith efforts.

• Brand Name: ULTRATOME XL
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15672741
• MDR Text Key: 307095750
• Report Number: 3005099803-2022-06126
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: 08714729103257
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K930022
• 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: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00535900
• Device Catalogue Number: 3590
• Device Lot Number: 0029411723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1