MAUDE Adverse Event Report: GYRUS ACMI INC. NEPHRO-EZDILATE KIT 30FR (10MM) X 15CM URETERAL BALLOON DILATION CATH; CATHETER, NEPHROSTOMY

Model Number BPCN1015K

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2018

Event Type  malfunction  

Event Description

The balloon dilator failed to dilate the tract completely.According to the staff, it was kinked in the middle.Therefore in view of this finding, the surgeon decided to switch in the middle of procedure and utilized the amplatz dilator with the steps going from a 20 to a 26 without any complications.

• Brand Name: NEPHRO-EZDILATE KIT 30FR (10MM) X 15CM URETERAL BALLOON DILATION CATH
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01772
• MDR Report Key: 7320209
• MDR Text Key: 101769835
• Report Number: 7320209
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2020
• Device Model Number: BPCN1015K
• Device Lot Number: 17101904
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES
• Patient Age: 50 YR
• Patient Weight: 95