MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUSTICK II; INTRODUCER, CATHETER

Model Number 35615

Device Problem Material Separation (1562)

Patient Problems Pain (1994); Discomfort (2330); Foreign Body In Patient (2687)

Event Date 08/09/2022

Event Type  Injury  

Event Description

It was reported that the metal ring marker dislodged and was left inside the patient.A.038 accustick ii system was selected for use for a percutaneous nephrostomy tube placement to treat hydronephrosis.A percutaneous stick was performed from the skin to the kidney.The accustick set sheath was then attempted to be removed.However, the metal ring marker of the tip of the sheath became dislodged and separated somewhere in the soft tissues deep in the abdominal wall.It was determined that advancing a nephrostomy tube over the wire would push the tiny metallic ring into the kidney as the ring was obviously around the wire since it became dislodged while removing the catheter over the wire.The physician decided to remove the access and leave the metal ring behind and obtain a second access point.It was then determined to leave the metal ring instead of retrieving it as it might cause the patient more harm and pain.The procedure was completed using alternate method or device.The patient felt discomfort/pain but was fully recovered.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.It was observed that the radiopaque marker was detached from sheath and the sheath distal tip was damaged.Microscopic inspection revealed that the device was damaged at the distal tip.Evidence of correct radiopaque marker colocation was observed at sheath distal end section; however, the radiopaque marker was detached from the shaft.The costumer attached x-ray pictures of the devices showing the metal ring or radiopaque marker and the second access site that was accessed using a second accustick and an 035 wire.

Event Description

It was reported that the metal ring marker dislodged and was left inside the patient.A.038 accustick ii system was selected for use for a percutaneous nephrostomy tube placement to treat hydronephrosis.A percutaneous stick was performed from the skin to the kidney.The accustick set sheath was then attempted to be removed.However, the metal ring marker of the tip of the sheath became dislodged and separated somewhere in the soft tissues deep in the abdominal wall.It was determined that advancing a nephrostomy tube over the wire would push the tiny metallic ring into the kidney as the ring was obviously around the wire since it became dislodged while removing the catheter over the wire.The physician decided to remove the access and leave the metal ring behind and obtain a second access point.It was then determined to leave the metal ring instead of retrieving it as it might cause the patient more harm and pain.The procedure was completed using alternate method or device.The patient felt discomfort/pain but was fully recovered.

• Brand Name: ACCUSTICK II
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15322349
• MDR Text Key: 298910028
• Report Number: 2124215-2022-31835
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 08714729157601
• UDI-Public: 08714729157601
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0029120807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• 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 Outcome(s): Required Intervention