MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; BALLOON DILATOR

Model Number	M00558660
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2018
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 pro wireguided dilatation balloon was used in the duodenal bulb during an esophagogastroduodenoscopy (egd) with dilation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, it was noted that the balloon ruptured.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Problem code 1074 captures the reportable issue of balloon burst.Investigation results visual examination of the returned complaint device revealed no visual defects.Functional analysis was performed, and the balloon was inflated normally.There were no leaks, holes or pinholes noted in the balloon.The returned device review (visual, physical, and/or performance testing) showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.  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 pro wireguided dilatation balloon was used in the duodenal bulb during an esophagogastroduodenoscopy (egd) with dilation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, it was noted that the balloon ruptured.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.

• Brand Name: CRE PRO
• Common Device Name: BALLOON DILATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7877231
• Report Number: 3005099803-2018-60437
• Device Sequence Number: 10797128
• Product Code: FGE
• UDI-Device Identifier: 08714729797548
• UDI-Public: 08714729797548
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K112994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018

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: 12/31/2019
• Device Model Number: M00558660
• Device Catalogue Number: 45757
• Device Lot Number: 0020132239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1