MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PASSPORT?; DILATOR, CATHETER, URETERAL

Model Number M0062181100

Device Problems Bent (1059); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2015

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a passport balloon dilatation catheter was used during a ureteroscopy (urs) procedure performed on (b)(6) 2015.According to the complainant, during preparation, the physician found that the tip was bent when the device was inserted into the scope channel.They kept trying with the insertion, which further bent the device.The procedure was completed with another passport balloon dilatation catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

Visual examination of the returned passport balloon dilatation catheter revealed that shaft of the device identified no kinks or damage.The flexi tip section of the device was bent which is a type of damage consistent with excessive force being applied to the tip section of the device.The balloon was examined and no issues with the balloon profile were found.Therefore, the condition of the returned device confirms the reported event of catheter tip bent.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 labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that a passport balloon dilatation catheter was used during a ureteroscopy (urs) procedure performed on (b)(6) 2015.According to the complainant, during preparation, the physician found that the tip was bent when the device was inserted into the scope channel.They kept trying with the insertion, which further bent the device.The procedure was completed with another passport balloon dilatation catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: PASSPORT?
• Type of Device: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4729636
• MDR Text Key: 18258395
• Report Number: 3005099803-2015-01076
• Device Sequence Number: 1
• Product Code: EZN
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K941853
• 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: 04/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2017
• Device Model Number: M0062181100
• Device Catalogue Number: 218-110
• Device Lot Number: 17483380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR