MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH RESCUENET¿ RETRIEVAL NET

Model Number DGN-538-5

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2017

Event Type  Injury  

Manufacturer Narrative

The reported lot number 170318246 did not match with the upn provided (b)(4) therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).Manufacturing site name -.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

Note: this report pertains to the second of five devices used during the same procedure.Refer to manufacturer report # 3005099803-2017-03734, 3005099803-2017-03736, 3005099803-2017-03737 and 3005099803-2017-03738 for the other associated device information.It was reported to boston scientific corporation that five rescuenet retrieval devices were used during an esophagogastroduodenoscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the net completely detached from the loop on five devices used consecutively.The detached components were retrieved successfully with forceps and the procedure was completed with a different device.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 good.

• Brand Name: RESCUENET¿ RETRIEVAL NET
• Type of Device: RETRIEVAL NET
• 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: 7118531
• MDR Text Key: 94885776
• Report Number: 3005099803-2017-03735
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152580
• 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
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DGN-538-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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