MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER NOTTINGHAM ONE-STEP; DILATOR, CATHETER, URETERAL

Model Number M0062301000

Device Problems Bent (1059); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a nottingham one-step ureteral dilator was received bent or folded.Neither procedure nor patient was involved.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Event Description

It was reported to boston scientific corporation that a nottingham one-step ureteral dilator was received bent or folded.Neither procedure nor patient was involved.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

A visual examination of the returned device revealed that the pouch was folded in half.The dilator was bent/kinked in several locations along its working length and the tip was kinked approximately 2cm from the distal end.Based on all gathered information, the most probable root cause is handing damage.A review of the device history record (dhr) was performed; no deviation was found.A search of the complaint database revealed that two similar complaints exist for the specified lot.

• Brand Name: NOTTINGHAM ONE-STEP
• Type of Device: DILATOR, CATHETER, URETERAL
• 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: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4170194
• MDR Text Key: 5021853
• Report Number: 3005099803-2014-03359
• Device Sequence Number: 1
• Product Code: EZN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K851144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/27/2018
• Device Model Number: M0062301000
• Device Catalogue Number: 230-100
• Device Lot Number: 17237755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1