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

Model Number M00521230

Device Problems Component Missing (2306); Activation, Positioning or Separation Problem (2906)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); No Code Available (3191)

Event Date 08/01/2019

Event Type  Death  

Manufacturer Narrative

The complainant was unable to report the device lot number; therefore the manufacture date and expiration date are 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 the duodenum/stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, the patient originally presented to the hospital with melena and hematemesis.Upon arrival to the hospital, the patient was brought to the intensive care unit (icu.In the icu, the patient received five units of blood, two units of blood plasma, and one unit of trombocytes.During the procedure, the clip was used in an attempt to stop stomach bleeding caused by a duodenal ulcer.The clip grasped and locked onto tissue, stopping the bleeding.However, the clip could not separate from the catheter and then had to be pulled off of the tissue.Reportedly, when the gastroscope and clip were withdrawn, the clip pulled tissue off of the site and the major bleeding restarted.Following the clip failure, the physician performed an exploratory laparotomy with the aim to suture arteria gastroduodenale.Three days after an esophagogastroduodenoscopy procedure and exploratory laparotomy surgery, the patient died.In the physician's assessment, the patient's cause of death was myocardial infarction.The physician believes that the cause of the myocardial infarction was pulmonary edema and circulatory collapse, related to the major surgery with complications that had been performed.The complainant further noted that the cause of the event was likely related to missing the instruction manual and other information.However, bsc was unable to confirm if the directions from use were missing from the packaging.

• 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
• Manufacturer (Section G): FREUDENBERG MEDICAL MIS (FM MIS); north port industrial park; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9347264
• MDR Text Key: 167148530
• Report Number: 3005099803-2019-05613
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875628
• UDI-Public: 08714729875628
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K151802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/20/2019
• 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): Death