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

Model Number	M00558340
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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.
Event or Problem Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.It was reported that when the physician unpacked the device, it was noticed that the balloon was ruptured.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: problem code a0402 captures the reportable event of balloon burst.Block h10: investigation results visual examination of the returned complaint device found that the balloon and the catheter of the device had no damages.Microscopic inspection was done and found the balloon had two holes, which does not confirm the reported event of balloon burst.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to two holes located in the distal section of the body of the balloon.It is possible that during the removal of the protector the balloon could hit any surface and of this way generate the holes found during the preparation.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.
Event or Problem Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.It was reported that when the physician unpacked the device, it was noticed that the balloon was ruptured.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.

• Brand Name: CRE FIXED WIRE
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11680323
• Report Number: 3005099803-2021-01744
• Device Sequence Number: 19737260
• Product Code: KNQ
• UDI-Device Identifier: 08714729201991
• UDI-Public: 08714729201991
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K971320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: 07/14/2021
• Device Model Number: M00558340
• Device Catalogue Number: 5834
• Device Lot Number: 0024103932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 50