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

Model Number M00521231

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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.(b)(4).

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used during a colonoscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, subsequent to successful deployment of the clip, the hypotube came off.It was retrieved with a non-bsc forceps, and the procedure was completed at this time.  there were no reported complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Mfg.Site name - (b)(4).Investigation results: visual examination revealed that only the crimped hypotube was returned for analysis.This failure is likely due to anatomical/procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device was manufactured in accordance with the device master record.A labeling review was performed and from the information available, this device was used per the directions for use (dfu) / product label.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used during a colonoscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, subsequent to successful deployment of the clip, the hypotube came off.It was retrieved with a non-bsc forceps, and the procedure was completed at this time.There were no reported complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6500060
• MDR Text Key: 73020821
• Report Number: 3005099803-2017-01087
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2018
• Device Model Number: M00521231
• Device Lot Number: 0000056088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2017
• 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
• Patient Outcome(s): Required Intervention