MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH RESOLUTION 360¿ CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number M00521232

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.(b)(4).

Event Description

It was reported to boston scientific corporation that an esophagogastroduodenoscopy (egd) procedure was performed in the stomach on an unknown date.According to the complainant, during reprocessing of the scope after the procedure, a resolution 360 clip device was found within the scope channel.It was reported that no clip device was used in this procedure, and the clip was therefore from a past procedure on an unknown date.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 fine.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Event Description

It was reported to boston scientific corporation that an esophagogastroduodenoscopy (egd) procedure was performed in the stomach on an unknown date.According to the complainant, during reprocessing of the scope after the procedure, a resolution 360 clip device was found within the scope channel.It was reported that no clip device was used in this procedure, and the clip was therefore from a past procedure on an unknown date.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 fine.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on july 24,2018.It was reported that both procedures occurred on june 02, 2018.According to the complaint, the initial procedure was an esophagogastroduodenoscopy (egd) where one clip was deployed successfully and the second clip did not deploy and was ¿assumed that it would be excreted in the usual fashion¿.It was also noted in the second procedure that the biopsy channel was not used.

Manufacturer Narrative

Mfg site name - freudenberg medical.Medwatch #: (b)(4).

• Brand Name: RESOLUTION 360¿ CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7682972
• MDR Text Key: 113814887
• Report Number: 3005099803-2018-02181
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• PMA/PMN Number: K151802
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2021
• Device Model Number: M00521232
• Device Lot Number: 0000092286
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 55