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

Model Number	M00558390
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: visual examination of the complaint device revealed the device did not have any visual defects.Functional analysis was performed, and the balloon was inflated; however, a leak was found due to a pinhole located near the distal bond of the balloon.This failure is likely due to factors or conditions related to the procedure that could have affected its performance and its intended purpose, such as the technique used by the physician during the procedure, the amount of strength applied by the customer during the movement of the balloon and/or the interaction between the scope and the balloon.Therefore, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct on (b)(6) 2019.According to the complainant, after the balloon was unpacked it was noticed that the balloon had a hole.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Investigation results revealed that the balloon found a pinhole; therefore, this is now an mdr reportable event.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct on (b)(6) 2019.According to the complainant, after the balloon was unpacked it was noticed that the balloon had a hole.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Investigation results revealed that the balloon found a pinhole; therefore, this is now an mdr reportable event.
Additional Manufacturer Narrative
Problem code 1504 captures the reportable investigation result of balloon pinhole.Investigation results: visual examination of the complaint device revealed the device did not have any visual defects.Functional analysis was performed, and the balloon was inflated; however, a leak was found due to a pinhole located near the distal bond of the balloon.This failure is likely due to factors or conditions related to the procedure that could have affected its performance and its intended purpose, such as the technique used by the physician during the procedure, the amount of strength applied by the customer during the movement of the balloon and/or the interaction between the scope and the balloon.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• 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: 8764609
• Report Number: 3005099803-2019-03162
• Device Sequence Number: 11135329
• 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): 12/12/2019

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: 05/19/2021
• Device Model Number: M00558390
• Device Catalogue Number: 5839
• Device Lot Number: 0022268355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 55