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

Model Number	M00558480
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional 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 medwatch 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 an endoscopic retrograde cholangiopancreatography (ercp) with stone extraction procedure performed on (b)(6) 2021.During the procedure, the balloon was attempted to be inflated; however, it was noticed that the balloon could not be inflated.Reportedly, the balloon was removed from the patient and checked and there was a pinhole.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.
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 an endoscopic retrograde cholangiopancreatography (ercp) wth stone extraction procedure performed on (b)(6) 2021.During the procedure, the balloon was attempted to be inflated; however, it was noticed that the balloon could not be inflated.Reportedly, the balloon was removed from the patient and checked and there was a pinhole.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a041001 captures the reportable event of balloon pinhole.Block h10: investigation result a visual examination of the returned complaint device found that the balloon and the catheter of the device did not have any damages.The balloon was returned covered with the protective sleeve.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to two pinholes in the distal and medium section on the body of the balloon.Media analysis of the photo submitted by the customer confirmed the pinholes in the distal and medium section of the balloon.The presence of a pinhole confirms the reported event.It is possible that the technique used by the physician and/or the interaction with the scope when the physician advanced the balloon could have caused that the balloon was damage during the procedure.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.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.

• 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: 12323727
• Report Number: 3005099803-2021-04095
• Device Sequence Number: 4713275
• Product Code: KNQ
• UDI-Device Identifier: 08714729339410
• UDI-Public: 08714729339410
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K110833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: 10/24/2023
• Device Model Number: M00558480
• Device Catalogue Number: 5848
• Device Lot Number: 0026406466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 58