MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK CRE? WIREGUIDED; DILATOR, ESOPHAGEAL

Model Number M00558480

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used during an endoscopic retrograde cholangiopancreatography (ercp) in the common bile duct performed on (b)(6) 2014.According to the complainant, during the procedure, the balloon leaked.The procedure was completed with another cre balloon.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.Investigation results revealed the exit marker to be loose and not in the correct position of the catheter shaft , therefore, this is now an mdr reportable event.

Manufacturer Narrative

(b)(4) for the investigation results of exit marker to be loose.A visual examination of the complaint device revealed that the catheter shaft had three kinks.The exit marker was found to be loose and not in the correct position of the catheter shaft.The balloon was found to be relaxed.Functional evaluation of the complaint device found that the balloon was able to be inflated and no leak was noted.Based on the condition of the returned device, the reported failure of balloon leaked was not confirmed.However, the investigation found the exit marker to be loose, which is contrary to what was originally reported.It is possible that the kinks caused in the physician having difficulty removing the catheter which resulted in the exit marker becoming loose; this however cannot be conclusively determined.This failure likely occurred due to anatomical/ procedural factors which limited the performance of the balloon.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.

• Brand Name: CRE? WIREGUIDED
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4262534
• MDR Text Key: 5009843
• Report Number: 3005099803-2014-03592
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K110833
• 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
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: M00558480
• Device Catalogue Number: 5848
• Device Lot Number: 17055240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2014
• 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
• Patient Age: 55 YR