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

Model Number	M00558390
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the common bile duct (cbd) during a lithotomy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon was leaking liquid.Reportedly, the balloon was removed from the scope and the balloon was noted to have ruptured.The procedure was completed with another cre wireguided dilatation 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 stable.
Additional Manufacturer Narrative
(b)(4).A visual examination of the complaint device revealed that there were no visual defects.Functional analysis was performed, the balloon was inflated, and a leak was found due to a pinhole located at the proximal shoulder of the balloon.The most probable root cause is manufacturing deficiency, as the design or validation of a suppliers manufacturing process was not sufficient to ensure the finished device met the intent of the design.An investigation to address this issue has been completed.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the common bile duct (cbd) during a lithotomy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon was leaking liquid.Reportedly, the balloon was removed from the scope and the balloon was noted to have ruptured.The procedure was completed with another cre wireguided dilatation 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 stable.

• Brand Name: CRE WIREGUIDED
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7995976
• Report Number: 3005099803-2018-60786
• Device Sequence Number: 16215644
• Product Code: FDF
• UDI-Device Identifier: 08714729339328
• UDI-Public: 08714729339328
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2020
• Device Model Number: M00558390
• Device Catalogue Number: 45735
• Device Lot Number: 0021212808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Received by Manufacturer: 09/29/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 55