MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP LEFT ATRIAL PRESSURE MONITORING CATHETER; APPARATUS, AUTOTRANSFUSION

Model Number 50010

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be made available by the customer for medtronic's analysis.The investigation is ongoing.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use the tip of this dlp left atrial pressure monitoring catheter placement set broke off inside the patient and was subsequently removed.The customer was unable to provide additional patient, product, or procedural information related to this incident.It is unknown how long the catheter placement set was in the patient, how the catheter placement set was being handled at the time of the reported break, or what procedure was required to remove the catheter placement set from the patient.No serious injury, additional medical intervention, or follow-up care related to this incident was reported.

Manufacturer Narrative

Medtronic investigation: the issue of the broken pressure monitoring catheter is confirmed based on the photo provided by the customer.It is unknown what may have caused this issue, and the root cause of this occurrence cannot be determined without the returned product.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.No trends warranting escalation related were evident to this occurrence 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

Medtronic received information that during use the tip of this dlp left atrial pressure monitoring catheter placement set broke off inside the patient and was subsequently removed.See the attached image.The customer was unable to provide additional patient, product, or procedural information related to this incident.It is unknown how long the catheter placement set was in the patient, how the catheter placement set was being handled at the time of the reported break, or what procedure was required to remove the catheter placement set from the patient.No serious injury, additional medical intervention, or follow-up care related to this incident was reported.

• Brand Name: DLP LEFT ATRIAL PRESSURE MONITORING CATHETER
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 8653338
• MDR Text Key: 146471470
• Report Number: 2184009-2019-00028
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 20613994654056
• UDI-Public: 20613994654056
• Combination Product (y/n): N
• PMA/PMN Number: K841482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 50010
• Device Catalogue Number: 50010
• Device Lot Number: 2017070049
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention