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

Model Number	M00547010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Note: this report pertains to one of three extractor pro retrieval balloons used during the same procedure.It was reported to boston scientific corporation that three extractor pro rx retrieval balloon devices were used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the catheter broke when attempted to extract the stone.The same issue occurred on the second and third extractor pro retrieval balloons.The procedure was completed with another extractor pro rx retrieval balloon.There have been no patient complications 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 1069 captures the reportable issue of catheter broken.Block h10: investigation results visual examination of the returned complaint device found the balloon did not show visual defects and looked normal.Additionally, it was noted that the shaft of the device was kinked and stretched.The outer diameter of the catheter was measured in two locations and were both found to be within specifications.A functional evaluation was also performed and the balloon was inflated up to its recommended inflation volumes and no issues were noted; there were no leaks, holes, pinholes this failure is likely due to factors or conditions related to procedure during the use of the device, such the handling of the device and/or the technique used by the physician, 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
Note: this report pertains to one of three extractor pro retrieval balloons used during the same procedure.It was reported to boston scientific corporation that three extractor pro rx retrieval balloon devices were used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on december (b)(6) according to the complainant, during the procedure, it was noted that the catheter broke when attempted to extract the stone.The same issue occurred on the second and third extractor pro retrieval balloons.The procedure was completed with another extractor pro rx retrieval balloon.There have been no patient complications as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

• 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: 9527203
• Report Number: 3005099803-2019-06307
• Device Sequence Number: 11341232
• Product Code: FGE
• UDI-Device Identifier: 08714729790297
• UDI-Public: 08714729790297
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K102082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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: 07/14/2021
• Device Model Number: M00547010
• Device Catalogue Number: 4701
• Device Lot Number: 0024104865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1