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

Model Number	M00511751
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an optiflo hemostasis catheter was to be used in the colon during an endoscopic mucosal resection procedure performed on (b)(6) 2021.After opening the package, it was noted that the inner device packaging was damaged and the sterile seal was compromised.The procedure was completed with another optiflo hemostasis catheter.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 stable.
Additional Manufacturer Narrative
Block e1: initial reporter address 2: (b)(6) this event was reported by the distributor.The reported physician and healthcare facility information are: (b)(6) block h6: medical device problem code a020503 captures the reportable event of packaging seal compromised.Block h10: investigation results the reported optiflo hemostatis catheter needle package was not received for analysis.Product could not be analyzed since original package reported as open was not received.The reported complaint is not confirmed since original package was not received.Based on the information available and the analysis performed, the most probable root cause for this problem is cause not established.A documental investigation within e-dhr (electronic device history record) was performed and no non conformances or deviations that contributed to the reported event were found.
Event or Problem Description
It was reported to boston scientific corporation that an optiflo hemostasis catheter was to be used in the colon during an endoscopic mucosal resection procedure performed on (b)(6) 2021.After opening the package, it was noted that the inner device packaging was damaged and the sterile seal was compromised.The procedure was completed with another optiflo hemostasis catheter.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 stable.

• 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
• Manufacturer (Section G): LAKE REGION MEDICAL; 31c butterfield trail; el paso TX 79906
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12919400
• Report Number: 3005099803-2021-05935
• Device Sequence Number: 17389216
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022

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: 08/01/2023
• Device Model Number: M00511751
• Device Catalogue Number: 1175
• Device Lot Number: 0006485898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 49 KG