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

Model Number	M00547050
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported the device was not used past its expiry date.(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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was used in the common bile duct during a bile duct stone removal procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon was unable to be deflated.After trying several times, the balloon was finally able to deflate, but despite this, it was still difficult to manipulate the balloon and perform fluoroscopy/contrast imaging.The procedure was completed with another extractor pro rx retrieval 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 an extractor pro rx retrieval balloon was used in the common bile duct during a bile duct stone removal procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon was unable to be deflated.After trying several times, the balloon was finally able to deflate, but despite this, it was still difficult to manipulate the balloon and perform fluoroscopy/contrast imaging.The procedure was completed with another extractor pro rx retrieval balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported the device was not used past its expiry date.Block h6: problem code a1401 captures the reportable event of balloon failed to deflate.Block h10: investigation result visual examination of the returned complaint device found the balloon did not show visual defects and was in a good condition.The balloon was returned completely deflated.No damage was found on the catheter of the device.Functional analysis was performed and the balloon did inflate and deflate well.Dimensional examination of the catheter was performed and was measured in three sections; distal, medium and proximal.The three sections were within specification.Based on the available information and that the complaint device was able to deflate well, the most probable root cause for this complaint cannot be detected.

• Brand Name: EXTRACTOR PRO RX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11150941
• Report Number: 3005099803-2020-06656
• Device Sequence Number: 17123581
• Product Code: FGE
• UDI-Device Identifier: 08714729790303
• UDI-Public: 08714729790303
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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 Model Number: M00547050
• Device Catalogue Number: 4705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1