MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ACCUSTICK¿ II; INTRODUCER, CATHETER

Model Number M001207040

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the tip detached and remained inside patient's body.The target lesion was located in the femoral artery.An accustick¿ ii was selected for use.During procedure, the device was used to get access on a patient¿s femoral artery that had a lot of scar tissue and was then pulled out.However, it was noted that the radiopaque marker came off the tip of the introducer and remained in the patient¿s inguinal tissue.No attempts were done to retrieve the device fragment as it may cause more harm to the patient.The procedure was completed with this device.No further patient complications were reported and patient¿s status was stable.

Event Description

It was reported that the tip detached and remained inside patient's body.The target lesion was located in the femoral artery.An accustick¿ ii was selected for use.During procedure, the device was used to get access on a patient¿s femoral artery that had a lot of scar tissue and was then pulled out.However, it was noted that the radiopaque marker came off the tip of the introducer and remained in the patient¿s inguinal tissue.No attempts were done to retrieve the device fragment as it may cause more harm to the patient.The procedure was completed with this device.No further patient complications were reported and patient¿s status was stable.

Manufacturer Narrative

Device evaluated by mfr, eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: the device was returned to analysis.Unit was returned with its original pouch, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.Only an accustick introducer was returned (sheath).The device was visually inspected; the sheath is bent in the middle and it has the tip damaged.The ro marker detached from the sheath and it was not returned with the device.Marker impression on the sheath surface indicates the ro marker had been properly assembled and swaged onto the proper location.The sheath surface was scraped/ damaged as the ro marker was slid over the sheath material.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

• Brand Name: ACCUSTICK¿ II
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7654244
• MDR Text Key: 112845541
• Report Number: 2134265-2018-05990
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K952828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

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
• Device Expiration Date: 05/02/2021
• Device Model Number: M001207040
• Device Catalogue Number: 20-704
• Device Lot Number: 22072103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other