MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA; CATHETER, BILIARY, DIAGNOSTIC

Model Number 32337

Device Problems Break (1069); Defective Device (2588)

Patient Problem Pain (1994)

Event Date 08/03/2023

Event Type  malfunction  

Event Description

It was reported that the device was pulled and forced out with extreme pain to patient.An 8fr x 35cm flexima drainage catheter was used for inserting internal and external biliary drain.During the procedure, after placing the drain, the plastic inner stylet would not come out and eventually broke.The physician decided to cut the catheter hoping that would release the pigtail on the end of the catheter, but it did not help.The device was pulled and forced out which caused extreme pain to patient.Eventually, the physician was able to keep the wire access, while pulling out the catheter with the pigtail still formed and placed a non-boston scientific biliary drain over the wire.The device was completely removed from patient's body and the procedure was completed using an alternate device.

• Brand Name: FLEXIMA
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17638142
• MDR Text Key: 322156483
• Report Number: 2124215-2023-43523
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729454953
• UDI-Public: 08714729454953
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2024
• Device Model Number: 32337
• Device Catalogue Number: 32337
• Device Lot Number: 0027180543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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
• Patient Age: 57 YR
• Patient Sex: Female