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

Model Number	M00558880
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 a cre rx biliary dilatation balloon was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that it was hard to maintain 3 atm pressure on the balloon after few seconds of inflation.The nurse had to continually pump the handle to maintain the pressure of the balloon.Reportedly, the device was removed for inspection and a leak was noted in the balloon due to a pinhole at the balloon material.The procedure was completed at this time.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx biliary dilatation balloon was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that it was hard to maintain 3 atm pressure on the balloon after few seconds of inflation.The nurse had to continually pump the handle to maintain the pressure of the balloon.Reportedly, the device was removed for inspection and a leak was noted in the balloon due to a pinhole at the balloon material.The procedure was completed at this time.There were no patient complications reported 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 1504 captures the reportable event of balloon pinhole.Block h10: investigation results.A visual examination of the returned complaint device found that the balloon and the catheter did not have any visual defects and were in good condition.Functional evaluation was performed, and the balloon was inflated without problem; however, the balloon would not hold pressure due to a pinhole located at the proximal section of the balloon material.This failure is likely due to factors encountered during the procedure, such as the lesion characteristics, the manner in which the device was handled and manipulated, the technique used by the physician, and normal procedural difficulties encountered during the procedure, that could have affected device 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
It was reported to boston scientific corporation that a cre rx biliary dilatation balloon was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that it was hard to maintain 3 atm pressure on the balloon after few seconds of inflation.The nurse had to continually pump the handle to maintain the pressure of the balloon.Reportedly, the device was removed for inspection and a leak was noted in the balloon due to a pinhole at the balloon material.The procedure was completed at this time.There were no patient complications reported 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 1504 captures the reportable event of balloon pinhole.Block h10: investigation results: a visual examination of the returned complaint device found that the balloon and the catheter did not have any visual defects and looked normal.Functional evaluation was performed, and the balloon was inflated without problem; however, the balloon would not hold pressure due to a pinhole located at the proximal section of the balloon material.This failure is likely due to factors encountered during the procedure, such as the lesion characteristics, handling of the device, the technique used by the physician and normal procedural difficulties encountered during the procedure could have resulted in the failure reported; therefore, it is possible that factors and/or conditions related to procedure during the use of the device 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.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.Block h11: correction: block h10 (investigation results).

• Brand Name: CRE RX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9837514
• Report Number: 3005099803-2020-00856
• Device Sequence Number: 19157442
• Product Code: FGE
• UDI-Device Identifier: 08714729965435
• UDI-Public: 08714729965435
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K172520
• 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,Followup
• Report Date (Section B): 09/29/2020

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: 11/03/2022
• Device Model Number: M00558880
• Device Catalogue Number: 45767
• Device Lot Number: 0024871402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 04/14/2020; 09/03/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 05/11/2020; 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1