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

Model Number	M00558410
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
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 dilation balloon was used in the common bile duct (cbd) during an endoscopic papillostomy of the duodenum procedure performed on (b)(6) 2021.During the procedure, an attempt to inflate the balloon was made; however, the balloon deflated automatically.After imaging, it was noticed that there was leaking in the balloon.The balloon was withdrawn and found a hole when the physician re-inflated the balloon.Additional clarification to determine the size/nature of the hole has not been provided, so the reported event will be considered a pinhole.The procedure was completed with another cre wireguided dilation 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.
Additional Manufacturer Narrative
Block h6: problem code a041001 captures the reportable event of balloon pinhole.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 revealed a pinhole on the balloon.Functional testing of the device was able to inflate the balloon without problem; however, the balloon did not hold pressure due to the pinhole on the tip of the balloon.The analysis of the returned device confirmed the reported event.This failure is likely due to factors encountered during the procedure, such as handling or manipulation during the initial use or during the procedure that could have affected its performance and its intended purpose.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 wireguided dilation balloon was used in the common bile duct (cbd) during an endoscopic papillostomy of the duodenum procedure performed on (b)(6) 2021.During the procedure, an attempt to inflate the balloon was made; however, the balloon deflated automatically.After imaging, it was noticed that there was leaking in the balloon.The balloon was withdrawn and found a hole when the physician re-inflated the balloon.Additional clarification to determine the size/nature of the hole has not been provided, so the reported event will be considered a pinhole.The procedure was completed with another cre wireguided dilation 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.

• 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: 11610641
• Report Number: 3005099803-2021-01374
• Device Sequence Number: 3280602
• Product Code: KNQ
• UDI-Device Identifier: 08714729339342
• UDI-Public: 08714729339342
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 04/28/2023
• Device Model Number: M00558410
• Device Catalogue Number: 5841
• Device Lot Number: 0025543626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 03/06/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 75