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	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.The complainant was unable to provide the serial number.Therefore, the manufacture date is unknown.(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 pneumatic inflator was used during a procedure performed on an unknown date.According to the complainant, the pressure on the gauge does not go back to zero.There have been no patient complications reported as a result of this event.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.Mfr site email: (b)(6).Problem code 1184 captures the reportable issue of gauge reading inaccurate.Investigation results: visual examination of the returned complaint device revealed no visual defects.Functional evaluation was then performed; the gauge needle inflated to 20psi, but the inflated unit was 2psi too high.The needle was then reset, and upon retesting, the device performed within specifications.The test was performed five additional times with the same results within specification.Based on the analysis performed and the information provided, the device met all the manufacturing requirements; however, the device was manufactured in 2014, and the reported issue is most likely traced to improper routine or preventative maintenance.Therefore, the most probable root cause is cause traced to maintenance.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 pneumatic inflator was used during a procedure performed on an unknown date.According to the complainant, the pressure on the gauge does not go back to zero.There have been no patient complications reported as a result of this event.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d4 and h4 block b3: date of event: date of event was approximated to 05/01/2019 as no event date was reported.Block g1: mfr site email: (b)(6).Block h6: problem code 1184 captures the reportable issue of gauge reading inaccurate.Block h10: 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 used during a procedure performed on an unknown date.According to the complainant, the pressure on the gauge does not go back to zero.There have been no patient complications reported as a result of this event.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 8649913
• Report Number: 3005099803-2019-02758
• Device Sequence Number: 13962958
• Product Code: GBA
• UDI-Device Identifier: 08714729195450
• UDI-Public: 08714729195450
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K781772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2019

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 Model Number: M00553200
• Device Catalogue Number: 5320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 07/08/2019; 08/22/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 08/02/2019; 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1