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

Model Number M00535920

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Insufficient Information (4580)

Event Date 05/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(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 ultratome xl was inspected at the distribution site on (b)(6) 2021.Upon shipment receipt and boxes inspection, it was found that the packaging was damaged.It was reported that the sterile barrier was compromised.There was no procedure involved and the device was not used in the patient.Note: a photo of the complaint device inside the package was provided by the customer and shows a cut in the middle of the label of the device packaging.

Event Description

It was reported to boston scientific corporation that an ultratome xl was inspected at the distribution site on (b)(6), 2021.Upon shipment receipt and boxes inspection, it was found that the packaging was damaged.It was reported that the sterile barrier was compromised.There was no procedure involved and the device was not used in the patient.Note: a photo of the complaint device inside the package was provided by the customer and shows a cut in the middle of the label of the device packaging.

Manufacturer Narrative

Block e1 (initial reporter address 2): (b)(6) block h6 (device codes): medical device problem code a020504 captures the reportable event of tear, rip, or hole in the device packaging, compromising the sterile barrier.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the heat seal runs through the entire length of the pouch without any breakage.The pouch had a cut at the front (label side).Per media analysis, the pictures showed the package of the device labeled with lot number 26218401, and the pouch was cut which seemed to have been made with a sharp tool.No other problems with the device were noted.The reported event of packaging damaged was confirmed.Upon analysis, it was found that the pouch had a cut at the front (label side).Based on the condition of the device, the problem found could have been caused due to handling and manipulation during transport or storage.Also, using a sharp tool to open the corrugated box to take out the device from the box can lead to cut the pouch as shown in the evidence available.Based on all gathered information, the most probable root cause of this complaint is cause traced to transport/storage due to problems traced to the inappropriate transport or storage of the device.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: ULTRATOME XL
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11969567
• MDR Text Key: 255645972
• Report Number: 3005099803-2021-02757
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103318
• UDI-Public: 08714729103318
• Combination Product (y/n): N
• PMA/PMN Number: K930022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/20/2022
• Device Model Number: M00535920
• Device Catalogue Number: 3592
• Device Lot Number: 0026218401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1