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	09/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that catheter separation occurred.The target lesion was located in the liver.An 18/30 expel large capacity drainage catheter was placed for percutaneous drainage.During the two week follow up visit, it was noted that the catheter was broken into three pieces (proximal, middle and distal).The catheter was removed without any additional interventions.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
E1.Initial reporter address (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Unit returned in a generic plastic bag, the unit returned has catheter broken, as part of overall visual revision.The returned device matches with upn provided by the customer.The device was returned in three separate sections with evidence of cracks along the device and pigtail, also, the device has a section damage with a knob, no other damages or anomalies were noted.
Event or Problem Description
It was reported that catheter separation occurred.The target lesion was located in the liver.An 18/30 expel large capacity drainage catheter was placed for percutaneous drainage.During the two week follow up visit, it was noted that the catheter was broken into three pieces (proximal, middle and distal).The catheter was removed without any additional interventions.No patient complications were reported and the patient was fine.

• 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: 9192869
• Report Number: 2134265-2019-12448
• Device Sequence Number: 2599434
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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: 03/28/2022
• Device Model Number: 32904
• Device Catalogue Number: 32904
• Device Lot Number: 0023565441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR