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

Model Number	30935
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The catheter was returned with the metal cannula and trocar loaded, the cannula was unloaded without issues and a damage was encountered in the pigtail section.A torn section was observed in the pigtail section.The metal cannula was inserted through the catheter and no resistance was felt.
Event or Problem Description
Reportable based on device analysis completed with 15dec2020.It was reported that the device was damaged.A flexima apdl was selected for use and attached to the patient's abdomen.During preparation, it was noted that the device was damaged.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.However, device analysis revealed that there was a tear in the pigtail section.

• 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: 11028011
• Report Number: 2134265-2020-18015
• Device Sequence Number: 667814
• Product Code: FFA
• UDI-Device Identifier: 08714729323150
• UDI-Public: 08714729323150
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K944290
• 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
• Report Date (Section B): 12/17/2020

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: 07/23/2022
• Device Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0024159661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 72