MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPEL DRAINAGE CATHETER WITH TWIST-LOC HUB; CATHETER, BILIARY, DIAGNOSTIC

Model Number	32900
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suture broke.An 8.3/25 expel drainage catheter with twist-loc hub was selected for use and attached to the patient's right chest.During procedure, the doctor tried to insert the first catheter and felt lots of resistance.Upon checking the expel tip, it was noticed that the tip was deformed and not perfectly straight even with the stiffener inside.When using the second catheter, it was noted that the suture broke.Both devices were manually removed the same way it was inserted and the procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.
Event or Problem Description
It was reported that the suture broke.A 8.3/25 expel drainage catheter with twist-loc hub was selected for use and attached to the patient's right chest.During procedure, the doctor tried to insert the first catheter and felt lots of resistance.Upon checking the expel tip, it was noticed that it was deformed and not perfectly straight even with the stiffener inside.When using the second catheter, it was noted that the suture broke.Both devices were manually removed the same way it was inserted and the procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the catheter was returned with the metal cannula and trocar loaded and no anomalies or damages were encountered.It was possible to observed the pigtail in a correctly shape.Additionally, the flexible cannula was received with the catheter and no anomalies were observed.The metal cannula was unloaded without issues, moreover, no issues were observed in the metal cannula, trocar and catheter.The suture string was observed in a correct shape and no issues were observed.Functional inspection revealed that a metal cannula and trocar were inserted and retracted form the catheter and no resistance was felt.

• Brand Name: EXPEL DRAINAGE CATHETER WITH TWIST-LOC HUB
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11141623
• Report Number: 2134265-2020-18515
• Device Sequence Number: 631911
• Product Code: FGE
• UDI-Device Identifier: 08714729860587
• UDI-Public: 08714729860587
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K141335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 32900
• Device Catalogue Number: 32900
• Device Lot Number: 0025943042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1