MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PNEUMATIC INFLATOR; CATHETER, BALLOON TYPE

Model Number	M00553200
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 pneumatic inflator was during an esophagogastroduodenoscopy (egd) with achalasia balloon dilation procedure performed in the esophagus on (b)(6) 2020.According to the complainant, during the procedure, when the balloon was inflated, the gauge needle was not working.Reportedly, the needle stayed at zero and did not increase, so there was no way to determine the actual inflation.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation that a pneumatic inflator was during an esophagogastroduodenoscopy (egd) with achalasia balloon dilation procedure performed in the esophagus on (b)(6) 2020.According to the complainant, during the procedure, when the balloon was inflated, the gauge needle was not working.Reportedly, the needle stayed at zero and did not increase, so there was no way to determine the actual inflation.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: problem code 1184 captures the reportable issue of gauge reading inaccurate.Block h10: investigation results: visual examination of the returned complaint device revealed no damage was found on the device.Functional evaluation was performed, and the device was inflated to 20 psi; there was no issues observed.This was repeated five times with the same results.The returned device review (visual, physical, and performance testing) showed no evidence of either the alleged or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint cannot be detected.

• Brand Name: PNEUMATIC INFLATOR
• Common Device Name: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9954156
• Report Number: 3005099803-2020-01549
• Device Sequence Number: 14156738
• Product Code: GBA
• UDI-Device Identifier: 08714729195450
• UDI-Public: 08714729195450
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K781772
• 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): 09/01/2020

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 Model Number: M00553200
• Device Catalogue Number: 5320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1