MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE; SYRINGE, BALLOON INFLATION

Model Number	M00566670
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.It was reported the device was not used past its expiry date.(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 an encore inflation device was used in a procedure performed in the colon on an unknown date.According to the complainant, during the procedure, it was noted that the gauge meter was defective which caused the balloon to rupture.The procedure was completed at this time.There were no patient complications reported as a result of this event.The patient¿s condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
A visual evaluation of the complaint device revealed no visible issues on the complaint device.A functional test was performed and found that the gauge needle was able to maintain pressure and was reading well.The returned device showed no evidence of either the alleged issue or any other defect which could have contributed to the event (visual, physical and performance testing).Therefore the root cause for this complaint cannot be confirmed.
Event or Problem Description
It was reported to boston scientific corporation that an encore inflation device was used in a procedure performed in the colon on an unknown date.According to the complainant, during the procedure, it was noted that the gauge meter was defective which caused the balloon to rupture.The procedure was completed at this time.There were no patient complications reported as a result of this event.The patient¿s condition at the conclusion of the procedure was reported to be good.

• Brand Name: SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6952530
• Report Number: 3005099803-2017-03088
• Device Sequence Number: 683074
• Product Code: MAV
• UDI-Device Identifier: 08714729755241
• UDI-Public: 08714729755241
• Combination Product (Y/N): N
• PMA/510(K) Number: K955869
• 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): 09/25/2017

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: M00566670
• Device Catalogue Number: 6667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1