MAUDE Adverse Event Report: COVIDIEN LLC BIOGLIDE®; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 91503

Device Problems Break (1069); Fracture (1260); Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

Event occurred in (b)(6).No products have been returned to medtronic for analysis.(b)(4) are applicable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a catheter used during a ventriculoperitoneal shunt surgery.It was reported that during the process of implanting the material, the doctor found that there was no right-angle clip in the cerebrospinal fluid shunt and accessories.They replaced it with a similar product, and the surgery went smoothly.Delay information was unknown.It was also unknown if the product made contact with the patient or patient with infection disease.It was reported that the product was not damaged.There was no reported impact to the patient.Additional information was received.It was reported that there was no delay.Cause was unknown.It was also unknown if the product made contact with that patient or if the clip was broken off of the shunt.

Manufacturer Narrative

H2, h3, h6: only the catheter and stylet was found in the returned product packaging.The seal of the pouch was opened.The right angle clip and female luer adapter were not found in the packaging.Dhr review did not show any anomalies in the manufacturing process.It was unknown how this damage may have occurred.Codes b01, c07, and d02 are applicable.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: BIOGLIDE®
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14219879
• MDR Text Key: 290169881
• Report Number: 9612501-2022-00679
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00763000027834
• UDI-Public: 00763000027834
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K951258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 91503
• Device Catalogue Number: 91503
• Device Lot Number: 0220913951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2020
• 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 Age: 56 YR
• Patient Sex: Female