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

Model Number	M00558460
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Investigation result: a visual examination of the returned complaint device revealed that the balloon did not have any visual defects.The catheter of the device was carefully inspected and no damages were found.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole in the distal section of its body.A labeling review was performed and from the information available, this device was not used per the directions for use (dfu)/product label as the device was pre-inflated.It is possible that the balloon being inflated prior to use could have caused the damage found in the balloon, thereby affecting the performance and intended purpose of the device and leading to in an inability to use it during the procedure.Based on the condition and evaluation of the returned device, the most probable root cause is failure to follow instructions since the problem was traced to the user not following the manufacturer's instructions.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used during a endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the biliary tract on (b)(6) 2019.According to the complainant, during preparation, the balloon was tested, and it was noticed that the balloon was leaking.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.

• 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: 8977281
• Report Number: 3005099803-2019-04370
• Device Sequence Number: 16967877
• Product Code: FDT
• UDI-Device Identifier: 08714729339397
• UDI-Public: 08714729339397
• 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
• Report Date (Section B): 09/09/2019

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: 08/16/2021
• Device Model Number: M00558460
• Device Catalogue Number: 5846
• Device Lot Number: 0022659220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/09/2019
• 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: 70