MAUDE Adverse Event Report: CELESTICA ELECTRONICS S PTE UNSPECIFIED BIS PRODUCT; ELECTRODE, CUTANEOUS

Model Number UNSPECIFIED BIS PRODUCT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Extubate (2402)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

Title: lung isolation for whole lung lavage in a pediatric patient with atypical airway anatomy due to short stature: a case report source: susan e.Eklund, md, and david n.Levin, md¿ date: april 30, 2019.(b)(4).If information is provided in the future, a supplemental report will be issued.[(b)(4)].

Event Description

According to literature, the patient¿s airway would not accommodate a traditional double-lumen tube.The endobronchial 4.0 tube was too short to extend beyond the mouth and was modified by removing the 10 mm adapter, cutting the dilated proximal end, applying isopropyl alcohol to the outside, then slipping a 5.0 uncuffed tube end-over-end.The bronchoscope was able to navigate past this transition point.With this final arrangement, there was a leak of approximately 10¿15 ml from the right lung, likely due to inadequate seal of the tracheal ett cuff against the bronchial.The patient was extubated on postprocedure day 1.After the second procedure, she was extubated approximately 5 hours postprocedure.She reported minimal discomfort after extubation.

Manufacturer Narrative

After review with medical affairs clinicians, it was determined that the bis device did not malfunction or contribute to the injury.The functionality experienced would be expected for this type (percussive) of therapy.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: UNSPECIFIED BIS PRODUCT
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): CELESTICA ELECTRONICS S PTE; no. 6 serangoon north avenue; singapore 55491 0; SG 554910
• MDR Report Key: 9342170
• MDR Text Key: 167002516
• Report Number: 2936999-2019-00954
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

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: UNSPECIFIED BIS PRODUCT
• Device Catalogue Number: UNSPECIFIED BIS PRODUCT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR
• Patient Weight: 22