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

Model Number	30935
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device size was not what was indicated on the package.An all purpose drainage was selected for use.During preparation, it was noted that the pigtail was not the size the package indicated.The procedure was completed with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The catheter returned with a loaded metal cannula, the catheter and the metal cannula looks in good condition, moreover, the catheter collar is labeled at 8fr.The length of the catheter, pigtail and french size were found to be within specification.The metal cannula was withdrawn and no resistance was found.
Event or Problem Description
It was reported that the device size was not what was indicated on the package.An all purpose drainage was selected for use.During preparation, it was noted that the pigtail was not the size the package indicated.The procedure was completed with another of the same device.There were no patient complications.

• 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: 9344071
• Report Number: 2134265-2019-14091
• Device Sequence Number: 2734087
• Product Code: FFA
• UDI-Device Identifier: 08714729323105
• UDI-Public: 08714729323105
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 12/17/2019

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 Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0023957445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1