MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INJECTION GOLD PROBE; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00560150

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that an injection gold probe needle was used during hemostasis procedure performed on (b)(6) 2022.During the preparation, it was found that injection needle is not coming out from the catheter.The procedure was not completed successfully.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.

Manufacturer Narrative

Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: investigation results: the returned optiflo hemostasis catheter was analyzed, and a visual evaluation noted that no damages or additional defects.A functional evaluation noted that the needle did not extend.Additionally, x ray analysis observed that the needle was kinked and broken.Based on all available information and the condition of the returned device, it is most likely procedural factors such as lesion characteristics, handling of the device, the technique used by the physician during the manipulation of the handle, and normal procedural difficulties encountered during the procedure that could have resulted in the damages encountered in the needle.The investigation concluded the most probable cause is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that an injection gold probe needle was used during hemostasis procedure performed on (b)(6) 2022.During the preparation, it was found that injection needle is not coming out from the catheter.The procedure was not completed successfully.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: INJECTION GOLD PROBE
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15071845
• MDR Text Key: 304516174
• Report Number: 3005099803-2022-03743
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: 08714729056492
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K133933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2022
• Device Model Number: M00560150
• Device Catalogue Number: 6015
• Device Lot Number: 0025748827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1