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

Model Number	M00547110
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was intended to be used in the common bile duct (cbd) for an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During preparation, it was noted that the shape of the balloon was irregular, which was confirmed via a photo submitted by the customer.The procedure was completed with another extractor pro xl retrieval balloon.There were no patient complications reported as a result of this event.
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.
Additional Manufacturer Narrative
Block h6: device code a0406 captures the reportable event of balloon irregular shape.Block h10: investigation results a visual examination of the returned complaint device found that the balloon and the catheter of device had no damages.Functional analysis was performed, and the balloon was inflated without a problem and held pressure.Dimensional examination of the balloon concentricity was performed and was within specification.No other problems with the device were noted.The reported event of balloon's shape crumple was not confirmed.The complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.Therefore, the most probable root cause cannot be determined as no problem was detected.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 instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was intended to be used in the common bile duct (cbd) for an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During preparation, it was noted that the shape of the balloon was irregular, which was confirmed via a photo submitted by the customer.The procedure was completed with another extractor pro xl retrieval balloon.There were no patient complications reported 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14876756
• Report Number: 3005099803-2022-03551
• Device Sequence Number: 4996569
• Product Code: FGE
• UDI-Device Identifier: 08714729790402
• UDI-Public: 08714729790402
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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: 02/14/2024
• Device Model Number: M00547110
• Device Catalogue Number: 4711
• Device Lot Number: 0028862813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown