MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPECT SLIMLINE SL; ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY

Model Number M00555510

Device Problem Unsealed Device Packaging (1444)

Patient Problems No Patient Involvement (2645); Insufficient Information (4580)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

(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 an expect slimline needle was opened on (b)(6) 2020.According to the complainant, during preparation, it was noticed that the device was received with the seal opened.Additionally, there was a mark that looked like it was cut with a cutter.There was no patient involvement in this case.

Event Description

It was reported to boston scientific corporation that an expect slimline needle was opened on december 18, 2020.According to the complainant, during preparation, it was noticed that the device was received with the seal opened.Additionally, there was a mark that looked like it was cut with a cutter.There was no patient involvement in this case.

Manufacturer Narrative

Block h6: device problem code 1444 captures the reportable event of packaging seal compromised.Block h10: investigation results the returned expect slimline needle was returned in its original box.The closure strip was opened when received.The device was taken out and inspected with no visual damages observed on the device/package.The box had signs of handling/manipulation, the box had a mark in the back likely made with a sharp tool.Based on all available information and the condition of the returned device, it is most likely that handling and manipulation of the device during transport/storage could have contributed with the encountered issue.Manipulation of the device can lead to damage on the box/package during transport/storage.The investigation concluded the most probable cause is cause traced to transport/storage.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: EXPECT SLIMLINE SL
• Type of Device: ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11158570
• MDR Text Key: 226552030
• Report Number: 3005099803-2020-06579
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 08714729848158
• UDI-Public: 08714729848158
• Combination Product (y/n): N
• PMA/PMN Number: K163058
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/19/2023
• Device Model Number: M00555510
• Device Catalogue Number: 5551
• Device Lot Number: 0025619355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1