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

Model Number	M00558670
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code a040609 captures the reportable event of balloon tip bent.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used for columnar balloon dilation of the bile duct and during endoscopic retrograde cholangiopancreatography (ercp), endoscopic sphincterotomy (est), and endoscopic nasobiliary drainage (enbd) procedures performed on (b)(6) 2022.During device unpacking, the tip was found to form a curvature and could not be used.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: device code a040609 captures the reportable event of balloon tip bent.Block h10: investigation results: the returned cre pro wireguided dilatation balloon was analyzed, and a visual examination found that the balloon and catheter of the device had no damages.Microscopic inspection found that the proximal tip of the guidewire was bent.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of tip bent was not confirmed.The problem found could have been interpreted by the customer as the reported event of tip bent.The "tip was found to form a curvature" was due to excess of manipulation against this unit.So, according to this evidence, it is most likely that as part of the device manipulation during preparation an excess of force was applied in order to get the device out of the package, causing the proximal section of the guidewire to get damaged.Therefore, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used for columnar balloon dilation of the bile duct and during endoscopic retrograde cholangiopancreatography (ercp), endoscopic sphincterotomy (est), and endoscopic nasobiliary drainage (enbd) procedures performed on (b)(6) 2022.During device unpacking, the tip was found to form a curvature and could not be used.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: CRE PRO
• 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: 16518084
• Report Number: 3005099803-2023-01142
• Device Sequence Number: 3353978
• Product Code: FGE
• UDI-Device Identifier: 08714729797555
• UDI-Public: 08714729797555
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112994
• 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): 05/15/2023

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: 03/05/2025
• Device Model Number: M00558670
• Device Catalogue Number: 5867
• Device Lot Number: 0029170187
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 63 KG