MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH RESOLUTION CLIP CLIPPING DEVICE; LIGATOR, ESOPHAGEAL

Model Number M00522610

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/25/2013

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on (b)(6) 2013 that a resolution clip device was used for hemostasis in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2013.According to the complainant, the initial procedure was completed without complications and the patient was discharged.Two days later on (b)(6) 2013, it was reported that the patient experienced bleeding "because the clip came off inside the patient".The patient went to the emergency room and received medications to treat the bleed.The patient was seen the next day by the physician who performed the egd and was confirmed to be okay.Attempts to obtain additional information, including patient, procedure and event information, have been unsuccessful to date.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported the device was not used past its expiry date.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.

• Brand Name: RESOLUTION CLIP CLIPPING DEVICE
• Type of Device: LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): MEDVENTURE TECHNOLOGY CORPORATION; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3186124
• MDR Text Key: 3519529
• Report Number: 3005099803-2013-05978
• Device Sequence Number: 1
• Product Code: MND
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00522610
• Device Catalogue Number: 2261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2013
• 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