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

Model Number M001207020

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2014

Event Type  malfunction  

Event Description

It was reported that during a renal access procedure, the dilator was protruding through the sheath.The physician was using a accustick ii system.038 j to access the renal artery.Once inserted into the patient, they noticed that the dilator was protruding through the sheath.They completed the procedure with another of the same device.No patient complications were reported and the patients' status is fine.

Event Description

It was reported that during a renal access procedure, the dilator was protruding through the sheath.The physician was using a accustick ii system.038 j to access the renal artery.Once inserted into the patient, they noticed that the dilator was protruding through the sheath.They completed the procedure with another of the same device.No patient complications were reported and the patients' status is fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: a visual examination identified one accustick ii with original, opened, and labeled pouch was received.No visible residue was found on the external surfaces of the device.The entire working length was bent.The needle cannula was protruding out of the dilator and sheath approximately 1.4cm from the distal end of the sheath.The distal tip of the sheath was deformed.The needle cannula was removed from the dilator and sheath; it was bent and covered in dried residue.The dilator was removed from the sheath; it was covered in dried residue and the tip was deformed.The dried residue was consistent with bodily fluids.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

• Brand Name: ACCUSTICK? II
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4169481
• MDR Text Key: 4867501
• Report Number: 2134265-2014-06353
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952828
• 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: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2017
• Device Model Number: M001207020
• Device Catalogue Number: 20-702
• Device Lot Number: 17163266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2014
• Initial Date FDA Received: 10/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2014
• 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: 43 YR
• Patient Weight: 131