MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPEL LARGE CAPACITY DRAINAGE CATHETER; CATHETER, BILIARY, DIAGNOSTIC

Model Number	32904
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the catheter break occurred.A 18/30 expel large capacity drainage catheter was selected for use in the patient's abdomen.The expel catheter was noted to be broken within the patient.The device was completely removed from the patient.The procedure was completed with this device.No complications reported and patient's condition is okay.
Event or Problem Description
It was reported that the catheter break occurred.A 18/30 expel large capacity drainage catheter was selected for use in the patient's abdomen.The expel catheter was noted to be broken within the patient.The device was completely removed from the patient.The procedure was completed with this device.No complications reported and patient's condition is okay.
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device was returned in two separate sections with evidence of cracks along the device.No other damages or anomalies were noted.

• Brand Name: EXPEL LARGE CAPACITY DRAINAGE CATHETER
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8401551
• Report Number: 2134265-2019-02145
• Device Sequence Number: 10840906
• Product Code: FGE
• UDI-Device Identifier: 08714729860723
• UDI-Public: 08714729860723
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K141335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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: 07/19/2021
• Device Model Number: 32904
• Device Catalogue Number: 32904
• Device Lot Number: 22405203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR