MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE WIREGUIDED; DILATOR, ESOPHAGEAL

Model Number	M00558470
Medical Device Problem Codes	Inflation Problem (1310); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 wireguided dilatation balloon was used during a gastroscopy procedure performed in the esophagus on (b)(6) 2019.According to the complainant, during the procedure, the balloon could not be inflated.It was noted that the wire was kinked at the balloon portion of the device.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Problem code 2981 for the reportable issue of distal tip bent.Investigation results: a visual examination of the returned complaint device found that the balloon and the catheter did not have any visual defects and was in a good condition.The guidewire was noticed to be kinked.A functional evaluation was also performed and the balloon was inflated up to its recommended inflation volumes and no issues were noted; there were no leaks, holes, pin holes noted and the balloon was able to hold the pressure.This failure is likely due to factors or conditions related to the procedure that could have affected its performance and its intended purpose, such as the technique used by the physician during the procedure, the amount of strength applied by the customer during the movement of the balloon and/or the interaction between the scope and the balloon.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 wireguided dilatation balloon was used during a gastroscopy procedure performed in the esophagus on (b)(6) 2019.According to the complainant, during the procedure, the balloon could not be inflated.It was noted that the wire was kinked at the balloon portion of the device.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.

• Brand Name: CRE WIREGUIDED
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8966009
• Report Number: 3005099803-2019-04420
• Device Sequence Number: 2088065
• Product Code: FDT
• UDI-Device Identifier: 08714729339403
• UDI-Public: 08714729339403
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K110833
• 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
• Report Date (Section B): 12/31/2019

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: 09/23/2021
• Device Model Number: M00558470
• Device Catalogue Number: 5847
• Device Lot Number: 0022838060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 12/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1