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

Model Number	M00558860
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, 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 during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon had a pinhole leak and did not properly inflate.The procedure was completed with another cre rx biliary dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Additional information: blocks d7 (sud reprocessed and reused?) and h8 (usage of device).Block h6: problem code a041001 captures the reportable event of balloon pinhole.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, 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 during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon had a pinhole leak and did not properly inflate.The procedure was completed with another cre rx biliary dilatation balloon.There were no patient complications reported as a result of this event.

• 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: 11803651
• Report Number: 3005099803-2021-02137
• Device Sequence Number: 11739645
• Product Code: FGE
• UDI-Device Identifier: 08714729965411
• UDI-Public: 08714729965411
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K172520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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 Expiration Date: 06/03/2022
• Device Model Number: M00558860
• Device Catalogue Number: 5886
• Device Lot Number: 0024057215
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1