MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA APDL; TUBE, DRAINAGE, SUPRAPUBIC

Model Number	30935
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the suture was broken.The target lesion was located in the common bile duct.A flexima apdl drainage catheter was selected for use.During procedure, the suture noted to be broken and the device was then simply pulled out from the patient's body.The procedure was completed with another of the same device.No complications reported and the patient condition was normal.
Event or Problem Description
It was reported that the suture was broken.The target lesion was located in the common bile duct.A flexima apdl drainage catheter was selected for use.During procedure, the suture noted to be broken and the device was then simply pulled out from the patient's body.The procedure was completed with another of the same device.No complications reported and the patient condition was normal.
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Device evaluated by the manufacturer.The device was returned for analysis.The unit returned has catheter cut/broken, as part of overall visual revision.The catheter returned the working length and suture string cut/detached at 7.5cm from the proximal section (hub end).

• Brand Name: FLEXIMA APDL
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8646163
• Report Number: 2134265-2019-05802
• Device Sequence Number: 2017186
• Product Code: FFA
• UDI-Device Identifier: 08714729323112
• UDI-Public: 08714729323112
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K944290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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: 01/31/2022
• Device Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0023258723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR