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

Model Number M00560150

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2019

Event Type  malfunction  

Manufacturer Narrative

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 emdr will be filed.

Event Description

It was reported to boston scientific corporation that an injection gold probe needle was used in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure when they were treating an active gi bleed, after cauterization, when the probe was pulled back, it was noticed that the tip of the probe almost came off.The procedure was completed with another injection gold probe needle.There were no patient complications reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

(b)(4).Investigation result: an injection gold probe was returned for analysis.A visual evaluation of the returned device revealed that the distal tip was detached and was not returned for analysis.In addition, a kink was noted in the middle section of the catheter and the needle was found bent.Since the issue occurred during the procedure and inside the patient, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Handling and manipulation of the device during its use can lead to kinking of the catheter and bending of the needle.Based on the evaluation of the returned device, a transversal cut was applied to the catheter, thread marks and the presence of glue were found, indicating that the device was properly assembled.However, without the tip being analyzed, it cannot be determined what could have generated this issue, therefore, cause not established was selected as the most appropriate conclusion code for this complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

Event Description

It was reported to boston scientific corporation that an injection gold probe needle was used in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure when they were treating an active gi bleed, after cauterization, when the probe was pulled back, it was noticed that the tip of the probe almost came off.The procedure was completed with another injection gold probe needle.There were no patient complications reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be fine.

• 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
• MDR Report Key: 8371320
• MDR Text Key: 137182536
• Report Number: 3005099803-2019-00745
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: 08714729056492
• Combination Product (y/n): N
• PMA/PMN Number: K133933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/28/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: M00560150
• Device Catalogue Number: 6015
• Device Lot Number: 20717592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2019
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 03/25/2019
• Supplement Dates FDA Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1