MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MALECOT NEPHROSTOMY CATHETERS; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Erosion (1750)

Event Date 08/04/2021

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report the device upn and lot number; therefore the manufacture date and expiration date are unknown.(b)(4).

Event Description

It was reported to boston scientific corporation that a malecot nephrostomy catheter was implanted on an unknown date.On (b)(6) 2021, the implanted catheter was accidentally pulled out during computed tomography (ct) scan.Subsequently, while cleaning the patient, it was noticed that the patient had a large soft bowel movement and had a circumferential breakdown inside the anal mucal membrane.The periwound was macerated and it was tender to clean the area.It was reported that a rectal pouch was then applied.No further information has been obtained despite good faith efforts.

• Brand Name: MALECOT NEPHROSTOMY CATHETERS
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15544206
• MDR Text Key: 301191300
• Report Number: 3005099803-2022-05641
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K820867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention