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

Model Number	M00547020
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 an extractor pro retrieval balloon was used during a common bile duct stone removal procedure performed on (b)(6) 2021.During the procedure, when balloon deflation was performed, the air on one side of the balloon could not be removed and the balloon did not deflate evenly.The procedure was completed with a different device of the same model.No patient complications have been reported as a result of the event.
Additional Manufacturer Narrative
Block d4: correction: model number: m00547020.Block h6: device code a1401 captures the reportable event of failure to deflate balloon.Block h10: the returned extractor pro retrieval balloon was analyzed, and a visual evaluation noted no damages to the catheter or balloon.A functional and microscopic evaluation noted that the balloon inflated without a problem and deflated unevenly but resumed its original shape.Dimensional inspection confirmed the balloon concentricity was within specification.No other problems with the device were noted.The reported event of failure to deflate the balloon was not confirmed.Evaluation of the balloon found no damages and confirmed it was within concentricity specification.When the balloon was deflated, it did not deflate evenly but, returned to its original shape and passed all concentricity measurements.Therefore the evaluation conclusion is "no problem detected" as the balloon passed all specifications and no problems with the device were noted.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro retrieval balloon was used during a common bile duct stone removal procedure performed on december 08, 2021.During the procedure, when balloon deflation was performed, the air on one side of the balloon could not be removed and the balloon did not deflate evenly.The procedure was completed with a different device of the same model.No patient complications have been reported as a result of the event.

• Brand Name: EXTRACTOR PRO RX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13172982
• Report Number: 3005099803-2021-08171
• Device Sequence Number: 11891648
• Product Code: FGE
• UDI-Device Identifier: 08714729790310
• UDI-Public: 08714729790310
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 08/09/2023
• Device Model Number: M00547020
• Device Catalogue Number: 4702
• Device Lot Number: 0027801437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown