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	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the drainage catheter detached and remained in the patient.A 6.3 flexima apdl was selected for a renal cyst puncture procedure under local anesthesia.During procedure, the catheter was placed to reach the renal cyst.The drainage catheter was put in place on the guide and the guide was removed.The cyst was drained with the drainage catheter, then it was injected with contrast product and it was removed by the drainage catheter, then injected with 40cc alcohol with a contact time of 15min.Then, when it was necessary to remove the alcohol only 10cc was removed, so the drainage catheter was moved in order to recover more alcohol.The physician noted a rupture in the drainage catheter and it detached inside the patient.One part of the detached fragment remained in the hands of the physician.An ultrasound scan performed that revealed a two fragment pieces of the drainage catheter were inside the patient.One part of the detached fragment remained in the cyst and another part was found in front of the cyst at the perirenal level.No surgery was performed to retrieve the two fragment pieces of the drainage catheter.

• 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: 10528460
• Report Number: 2134265-2020-12629
• Device Sequence Number: 14232641
• Product Code: FFA
• UDI-Device Identifier: 08714729323099
• UDI-Public: 08714729323099
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/10/2022
• Device Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0023258715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR
• Patient Weight: 64