MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) FLEXIMA¿ APDL; TUBE, DRAINAGE, SUPRAPUBIC

Model Number M001271350

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the patient experienced pain.The target area was located in the lower abdomen.A flexima¿ apdl was selected for percutaneous abscess drainage.During procedure, upon inserting the catheter inside patient¿s body using trocar technique, the catheter was advanced through the peritoneal muscle.However, resistance was encountered while pushing the catheter with excessive force against the tissue.Subsequently, the catheter was observed to have collapsed into the metallic axis.After multiple attempts of positioning the catheter, the patient experienced pain.Furthermore, while attempting to remove the metallic axis, the rotator broke and the metallic axis became stuck in the catheter.Thus, the entire catheter was manually removed from the patient¿s body and dilation was performed in the access site and compression was done to stop the bleeding of the access site.The procedure was then completed with another of the same catheter.No further patient complications reported and the patient¿s condition was stable.

• Brand Name: FLEXIMA¿ APDL
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7109743
• MDR Text Key: 95069748
• Report Number: 2134265-2017-12629
• Device Sequence Number: 1
• Product Code: FFA
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K944290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: M001271350
• Device Catalogue Number: 27-135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 80