MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE WIREGUIDED; DILATOR, ESOPHAGEAL

Model Number M00558430

Device Problems Material Puncture/Hole (1504); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2018

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(6).(b)(4).Investigation results: a visual examination of the returned complaint device found that the exit marker was bunched up.A functional examination was performed, the balloon was inflated and a leak was found due to a pinhole located at the distal shoulder of the balloon.This failure is likely due to adverse factors and/or conditions related to the procedure during the use of the device which limited the performance of the device.Therefore, the most probable root cause is cause traced to component failure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.It was found that the balloon had a pinhole and the exit marker was bunched-up.Reportedly, the procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.

• Brand Name: CRE WIREGUIDED
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8111249
• MDR Text Key: 128734594
• Report Number: 3005099803-2018-61655
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729339366
• UDI-Public: 08714729339366
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K110833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2020
• Device Model Number: M00558430
• Device Catalogue Number: 5843
• Device Lot Number: 0021260163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2017
• 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