MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXTRACTOR PRO XL; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00547110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual examination of the returned complaint device found the catheter detached in two separate sections, thereby confirming the reported event.It was also noted that the catheter was stretched and was kinked close to the proximal bond.The balloon was carefully inspected and no damages were found.Microscopic analysis was performed and confirmed that the catheter was stretched and kinked.It is possible that the physician had to apply more force than usual during the procedure while in the anatomy, and of this way the catheter stretched and kinked until one point where the material didn't support the tension over the device, resulting in the found failure of catheter break.Therefore, the most probable root cause is adverse event related to procedure because, the adverse event occurred during the procedure and the device had no influence on event.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 an extractor pro xl retrieval balloon device was used in the common bile duct (cbd) stone during an endoscopic retrograde cholangiopancreatography (ercp) with stone extraction procedure performed on (b)(6) 2021.It was reported that during the procedure, it was noted that the catheter sheared in half as it was being advanced into the working channel of the duodenoscope.It was reported that nothing detached into the patient.The procedure was completed with another extractor pro xl retrieval balloon.There have been no patient complications as a result of this event.

• Brand Name: EXTRACTOR PRO XL
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11362179
• Report Number: 3005099803-2021-00578
• Device Sequence Number: 3383555
• Product Code: FGE
• UDI-Device Identifier: 08714729790402
• UDI-Public: 08714729790402
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K102082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2021

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: 09/18/2021
• Device Model Number: M00547110
• Device Catalogue Number: 4711
• Device Lot Number: 0024456724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1