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	04/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suture broke.The target lesion was located in the ascites.A flexima apdl was selected for use.During procedure, when pulling the thread to form a catheter distal pigtail outside the patient's body, it was noted that the thread was cut and all portions of the thread became detached from the patient.The thread was completely removed and the procedure was completed with another of the same device.No additional intervention was necessary and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The catheter was returned, no defects were noted and it looks in good condition.The suture string was received cut and it was observed suture section inside the catheter and in the hub section.
Event or Problem Description
It was reported that the suture broke.The target lesion was located in the ascites.A flexima apdl was selected for use.During procedure, when pulling the thread to form a catheter distal pigtail outside the patient's body, it was noted that the thread was cut and all portions of the thread became detached from the patient.The thread was completely removed and the procedure was completed with another of the same device.No additional intervention was necessary and no patient complications were reported.

• 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: 10025245
• Report Number: 2134265-2020-06011
• Device Sequence Number: 16878349
• Product Code: FFA
• UDI-Device Identifier: 08714729323105
• UDI-Public: 08714729323105
• 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): 05/28/2020

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: 11/25/2022
• Device Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0024834484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR