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

Model Number M00558490

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.(b)(4).

Event Description

It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used during a dilatation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, it was noted that the balloon would not pass through the scope when it was inserted again for a second dilation; it was discovered that the exit marker of the device was moving.It was reported that the procedure could not be completed that day, so the patient was called back a few days later.No patient complications have been reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

A visual examination of the returned complaint device revealed that the black exit marker was bunched-up.The device was returned with the protective sleeve covering the balloon, though there were signs that it had been removed.No other issues or damages were noted on the device.Based on the condition of the returned device, the noted defects likely occurred due to anatomical or procedural factors encountered during the procedure.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 labeling review was performed and from the information available, this device was not used per the directions for use (dfu) / product label; the dfu states to apply silicone spray to the balloon prior to the procedure.A search of the complaint database revealed that no other complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used during a dilatation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, it was noted that the balloon would not pass through the scope when it was inserted again for a second dilation; it was discovered that the exit marker of the device was moving.It was reported that the procedure could not be completed that day, so the patient was called back a few days later.No patient complications have been reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: CRE¿ WIREGUIDED
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 7600842
• MDR Text Key: 111058711
• Report Number: 3005099803-2018-01831
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: K110833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: M00558490
• Device Catalogue Number: 5849
• Device Lot Number: 20956078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Date Manufacturer Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1