MAUDE Adverse Event Report: APPLIED MEDICAL B1005, ACUCISE ENDOPYELOTOMY SYSTEM

Model Number B1005

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2015

Event Type  malfunction  

Manufacturer Narrative

The incident device anticipated to return.A follow-up report will be provided upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.

Event Description

Endopyelotomy procedure - "dr.(b)(6) was performing the procedure and the balloon would not dilate during application.Territory manager (b)(6) was present during the procedure and carefully observed dr.(b)(6) for the instruction.The balloon dilated for approximately 2 sec and failed.(b)(6) also spoke with the physician immediately after the procedure.The larger (outer) box lot number is 1241965." intervention - "na".Patient status - "na".

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation.Engineering attempted to inflate balloon, to check for leakage; however, the balloon could not be inflated due to it being blocked.After removing the blockage, engineering attempted to re-inflate the balloon, but found the balloon was ruptured.The leakage may be attributed to high thermal activity of the cutting wire, which resulted in the balloon rupturing and causing it to be unable to remain inflated.A review of the manufacturing records indicates this lot passed all manufacturing and quality inspections.The hazard analysis for this device was reviewed and it was determined that the risk levels remain unchanged and acceptable.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• Brand Name: B1005, ACUCISE ENDOPYELOTOMY SYSTEM
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer (Section G): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: loananh nguyen ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 4988428
• MDR Text Key: 23982897
• Report Number: 2027111-2015-00498
• Device Sequence Number: 1
• Product Code: EYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K921838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/05/2015,12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/27/2016
• Device Model Number: B1005
• Device Catalogue Number: 100540501
• Device Lot Number: 1233689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1