MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RIGIFLEX II; DILATOR, ESOPHAGEAL

Model Number	M00554500
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a rigiflex ii dilatation balloon was used in the common bile duct (cbd) during a balloon dilatation procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon burst.The procedure was completed with another rigiflex ii dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2: additional information: block d7a (sud reprocessed and reused?).Block h6: device code a0402 captures the reportable event of balloon burst.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a rigiflex ii dilatation balloon was used in the common bile duct (cbd) during a balloon dilatation procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon burst.The procedure was completed with another rigiflex ii dilatation balloon.There were no patient complications reported as a result of this event.

• Brand Name: RIGIFLEX II
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12321605
• Report Number: 3005099803-2021-04074
• Device Sequence Number: 11762781
• Product Code: PID
• UDI-Device Identifier: 08714729719106
• UDI-Public: 08714729719106
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K050232
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: 02/11/2022
• Device Model Number: M00554500
• Device Catalogue Number: 5450
• Device Lot Number: C027377
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 08/21/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1