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

Model Number M00521232

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

(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 Description

It was reported to boston scientific corporation that a resolution 360 clip device was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the clip would not deploy.The procedure was successfully completed with an unknown device.No patient complications have been reported due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the clip would not deploy.The procedure was successfully completed with an unknown device.No patient complications have been reported due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.***additional information received on (b)(6), 2020*** it was reported that three resolution 360 clip devices were used in the lower esophagus during this procedure.The procedure was completed with another resolution 360 clip device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: device code 2906 captures the reportable event of clip would not deploy.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned".Block h10: according to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental mdr will be filed.Additional information: block b5 (describe event or problem), d8 (sud reprocessed and reused), h6 (patient code) h8 (usage of device), h10 (additional mfr narrative).

• Brand Name: RESOLUTION 360 CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10934438
• MDR Text Key: 219156830
• Report Number: 3005099803-2020-05865
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875642
• UDI-Public: 08714729875642
• 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: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2023
• Device Model Number: M00521232
• Device Catalogue Number: 54774
• Device Lot Number: 0026046371
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1