MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER AMPLATZ TYPE RENAL DILATOR/SHEATH SET; DILATOR, CATHETER, URETERAL

Model Number M0062602500

Device Problems Kinked (1339); Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2015

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an amplatz type renal dilator was used during a procedure performed on (b)(6) 2015.According to the complainant, during preparation outside of the patient, the device was found to be kinked.The procedure was completed with another amplatz renal dilator.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

One amplatz renal dilator set was received for analysis.Visual examination of the returned device revealed that several dilators in the set were bent.During manufacturing, the devices are 100% inspected for device integrity/specification.Based on all gathered information, the defect was identified outside the patient during preparation for the procedure.Therefore, the most probable root cause is handling damage.

Event Description

It was reported to boston scientific corporation that an amplatz type renal dilator was used during a procedure performed on (b)(6) 2015.According to the complainant, during preparation outside of the patient, the device was found to be kinked.The procedure was completed with another amplatz renal dilator.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.

• Brand Name: AMPLATZ TYPE RENAL DILATOR/SHEATH SET
• 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: 4802823
• MDR Text Key: 20772909
• Report Number: 3005099803-2015-01456
• Device Sequence Number: 1
• Product Code: EZN
• Combination Product (y/n): N
• PMA/PMN Number: K851144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0062602500
• Device Catalogue Number: 260-250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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