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

Model Number M00521230

Device Problems Entrapment of Device (1212); Problem with Sterilization (1596)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2019 as the event date of both procedures is unclear/unknown.(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.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used in a procedure.According to the complainant, during the procedure, the clip detached and remained in the working channel of the colonoscope.The procedure was completed at this time.During a separate procedure performed with the same colonoscope, there were difficulties with the scope performance.A clean brush was passed down the scope, and the clip was discovered.The procedure was completed at this time.The procedure date was reported to be (b)(6) 2019; however, it has not been specified which procedure occurred on this date.No patient complication have been reported as a result of the event.

Manufacturer Narrative

Block b3: date of event was approximated to (b)(6) 2019 as the event date of both procedures is unclear/unknown.Block d4, h4: the complainant was unable to report the device lot number; therefore, the manufacture date and expiration date are unknown.Block h6: problem code 1596 captures the reportable issue of the clip detached and remained in the working channel of the colonoscope, reprocessed, and used in another procedure.Block h10: 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.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used in a procedure.According to the complainant, during the procedure, the clip detached and remained in the working channel of the colonoscope.The procedure was completed at this time.During a separate procedure performed with the same colonoscope, there were difficulties with the scope performance.A clean brush was passed down the scope, and the clip was discovered.The procedure was completed at this time.The procedure date was reported to be (b)(6) 2019; however, it has not been specified which procedure occurred on this date.No patient complication have been reported as a result of the event.***additional information received on july 23, 2019*** it was reported that the procedure performed was colonoscopy.

• 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: 8808334
• MDR Text Key: 151634561
• Report Number: 3005099803-2019-03682
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875628
• UDI-Public: 08714729875628
• 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: 08/13/2019

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 Model Number: M00521230
• Device Catalogue Number: 54772
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/19/2019
• Supplement Dates Manufacturer Received: 07/23/2019
• Supplement Dates FDA Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1