MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH OPTIFLO HEMOSTASIS CATHETER; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M00511751
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was under the age of 18.Reported event of device failed to inject agent.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 optiflo hemostasis catheter needle device was during an endoscopic submucosal injection procedure performed on (b)(6) 2016.According to the complainant, during the procedure the device was unable to inject agent.The procedure was completed with another optiflo injection needle device.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that an optiflo hemostasis catheter needle device was during an endoscopic submucosal injection procedure performed on (b)(6) 2016.According to the complainant, during the procedure the device was unable to inject agent.The procedure was completed with another optiflo injection needle device.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on (b)(4) 2017, confirming the needle was blocked however the injection port was not occluded.Additionally on (b)(6) 2017, it was confirmed that the needle was able to extend out of the sheath.

• Brand Name: OPTIFLO HEMOSTASIS CATHETER
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6223942
• Report Number: 3005099803-2016-04093
• Device Sequence Number: 893164
• Product Code: KOG
• UDI-Device Identifier: 08714729145264
• UDI-Public: (01)08714729145264(17)20171001(10)E49096
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K953338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2016

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: 10/01/2017
• Device Model Number: M00511751
• Device Catalogue Number: 1175
• Device Lot Number: E49096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2017
• Supplement Report FDA Received Date: 02/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1