MAUDE Adverse Event Report: COVIDIEN LP BARRX BEACON; KIT, NEEDLE, BIOPSY

Model Number DSA-135-01

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the needle broke off into the patient's stomach.When they pulled the needle into the scope it did not leave its position.There was no resistance or abnormal sound heard or felt.It was confirmed on fluoroscopy.Everything worked fine until the needle was pulled back.The needle broke within the apparatus approximately 20cm or more if it broke of into the patient.It was suspected that the entire length of the needle broke from where it was hooked into the plastic of apparatus.The patient was fine and was kept overnight.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted found the tip of the needle had broken off.It was reported that the device broke in the patient and was retrieved using a rat tooth forceps and overtube.The reported issue was confirmed.The most likely cause was traced to supplier process.Process improvements have been initiated to mitigate this issue.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the needle broke off into the patient's stomach.The patient had a malignant pancreatic mass involving the proximal duodenum and compressed the mid common bile duct (cbd) and portal vein.Since the duodenum could not be reached with the endoscopic retrograde cholangiopancreatography (ercp) and they used rendezvous and planned on completing procedure with an esophagogastroduodenoscopy.They used a distal antrum as access point which gives a similar view as the duodenal bulb.They first used the 90 needle which worked well and the wire could not be advanced into the common bile duct and kept going into the intrahepatic's and given findings of 135 would gave them a better angle.The 90 was removed uneventfully and then used the 135.Initially the wire went into the intrahepatic's.They then rotated it 180 degrees or so without any issues and wire went into the common bile duct as standard (and wire was passed through ampulla).The physician pulled the needle into the scope and it did not leave its position.There was no resistance or abnormal sounds heard or felt.It was noted that the needle was broken as they could still see it on the device and after whole system was removed from the scope.Confirmed on fluoroscopy.Everything worked fine until the needle was pulled back.The needle broke from within the apparatus and approximately 20cm or more broke off into the patient.They guess was that the entire length of the needle broke from where it was hooked in to the plastic of the apparatus.The physician tried grasping using the forceps and they were unable to get a good grab.Snare was attempted and it failed to grab the needle.A rat tooth forceps and overtube was used to removed the needle.Fluoroscopy had been taken and there was not much elevator used during the case.The device was saved for return.There was no particularly risky portion of the procedure that would be expected to cause such a fracture.The dilation of probably about 11 or 12 m at the beginning of the procedure.There was no patient altered anatomy and tortuous scope position.Patient remained in the hospital due to underlying condition or illness.

Manufacturer Narrative

Additional information: a2, a3, b3, b5, e1(last name), e4(email), g4, h6.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BEACON
• Type of Device: KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 10153701
• MDR Text Key: 195124515
• Report Number: 3004904811-2020-00018
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10884521663527
• UDI-Public: 10884521663527
• Combination Product (y/n): N
• PMA/PMN Number: K180037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2020

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 Expiration Date: 08/06/2022
• Device Model Number: DSA-135-01
• Device Catalogue Number: DSA-135-01
• Device Lot Number: F2510861X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 06/17/2020; 09/14/2020
• Supplement Dates FDA Received: 07/03/2020; 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 50 YR