MAUDE Adverse Event Report: PERFUSION SYSTEMS CLEARVIEW ARTERIOTOMY SHUNT; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	31100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic requested the complaint device but were unable to determine the return status from the customer.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 or Problem Description
Medtronic received information that during use, the customer reported the 31100 arteriotomy shunt broke during removal from the patient's coronary artery.The shunt was successfully removed.The procedure was completed with no adverse effect to the patient.
Additional Manufacturer Narrative
Medtronic investigation: a photo provided by the customer shows a portion of the tubing and bulb is separated from the device.A 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.There were no adverse patient effects as a result of this incidence.There are no trends warranting escalation related to this occurrence.Medtronic will continue to monitor for future occurrences and trends.Conclusion: the quality checks that are in place would not allow for this type of defect to pass through our system and likely related to the technique used in handling the shunt.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLEARVIEW ARTERIOTOMY SHUNT
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 8338517
• Report Number: 2184009-2019-00004
• Device Sequence Number: 19396598
• Product Code: DWF
• UDI-Device Identifier: 00885074257112
• UDI-Public: 00885074257112
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K120612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 31100
• Device Catalogue Number: 31100
• Device Lot Number: 2017110959
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2019
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention