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

Model Number B1005

Device Problem Inflation Problem (1310)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/31/2015

Event Type  malfunction  

Manufacturer Narrative

Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent 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

Acucsie endopyelotomy - "dr.(b)(6) performed the procedure.The balloon did not stay inflated following activation of the cutting wire.Wire was activated for 5 seconds at 75w pure cut.Device was observed to hold inflation for cutting step of procedure, but when fluoroscopy was performed minutes after, no contrast solution remained in the balloon.Upon removal of device, damage to the balloon was observed.After removal of the device, a 2cc syringe of sterile water was injected into the balloon inflation port and leakage was confirmed.This b1005 was part of the bk002 kit lot 1248705." patient status - "na.".

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation.Upon testing, engineering identified a ruptured balloon and silicone sheath.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 indicated 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
• Type of Device: KNY
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5402510
• MDR Text Key: 37739489
• Report Number: 2027111-2016-00062
• Device Sequence Number: 1
• Product Code: KNY
• UDI-Device Identifier: 20607915128122
• UDI-Public: (01)20607915128122(17)170311(30)01(10)1242590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/11/2017
• Device Model Number: B1005
• Device Catalogue Number: 100540501
• Device Lot Number: 1242590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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