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

Model Number	M00511751
Medical Device Problem Codes	Unsealed Device Packaging (1444); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Insufficient Information (4580)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patients exact age is unknown; however, it was reported that the patient was over 18 years of age.(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 an optiflo needle was to be used during a procedure on (b)(6) 2020.According to the complainant, during unpacking the outer package, the sealing of the package had been opened.There were no patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an optiflo needle was to be used during a procedure on (b)(6) 2020.According to the complainant, during unpacking the outer package, the sealing of the package had been opened.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block a2: the patients exact age is unknown; however, it was reported that the patient was over 18 years of age.Block h6: medical device problem code a020503 captures the reportable issue of packaging seal compromised.Block h10: investigation results: the returned optiflo hemostasis catheter was analyzed, a visual evaluation was performed and the connector t detached from the handle.The defect of seal compromised was not confirmed since the original package was not included in the package.No other issues were noted.Based on all available information and the condition of the returned device, the investigation findings did not lead to a clear conclusion about the cause of the reported adverse event.The original package was not included, therefore the reported failure mode was not possible to confirm.The investigation concluded the most probable cause is cause not established.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: OPTIFLO HEMOSTASIS CATHETER
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11058626
• Report Number: 3005099803-2020-06380
• Device Sequence Number: 2975203
• Product Code: KOG
• UDI-Device Identifier: 08714729145264
• UDI-Public: 08714729145264
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K953338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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: 12/01/2021
• Device Model Number: M00511751
• Device Catalogue Number: 1175
• Device Lot Number: 0005135658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1