MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER 8/10 DILATOR/SHEATH SET; DILATOR, CATHETER, URETERAL

Model Number M0062601200

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an 8/10 dilator/sheath set was used during a percutaneous nephrolithotomy procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the distal tip of the dilator was detached inside the patient upon advancing the intro needle and was successfully retrieved.The procedure was completed with another 8/10 dilator/sheath set.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 stable.

Manufacturer Narrative

Visual examination of the returned renal dilator stylet and sheath revealed that the distal tip of the sheath was split and deformed and the sheath was kinked in several locations.The stylet was bent most likely due to the way it was packaged for return.Based on all gathered information, the most probable root cause classification is operational context.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that an 8/10 dilator/sheath set was used during a percutaneous nephrolithotomy procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the distal tip of the dilator was detached inside the patient upon advancing the intro needle and was successfully retrieved.The procedure was completed with another 8/10 dilator/sheath set.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 stable.

• Brand Name: 8/10 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: 4170315
• MDR Text Key: 5092830
• Report Number: 3005099803-2014-03370
• Device Sequence Number: 1
• Product Code: EZN
• Combination Product (y/n): N
• Reporter Country Code: SG
• 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: 09/25/2014

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: Physician
• Device Expiration Date: 02/19/2018
• Device Model Number: M0062601200
• Device Catalogue Number: 260-120
• Device Lot Number: 16757239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2014
• 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