MAUDE Adverse Event Report: PERFUSION SYSTEMS URCHIN EVO HEART POSITIONER; STABILIZER,HEART

Model Number	HP3500
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	11/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection of the returned urchin evo heart positioner showed no outward signs of damage.Investigation: performance testing indicated that the device functioned as intended.Conclusion: complaint cannot be confirmed.The adverse event was due to a customer mix-up involving the suction line from the urchin evo heart positioner.This resulted in suction close to 500 mm/hg causing damage to the patient's epicardium.Note: pma / 510(k) #: urchin evo (hp3500) is class i exempt.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 an inadvertent mix-up involving the suction line from the urchin evo heart positioner (suction on the urchin was close to 500 mm/hg).This resulted in tears in the patient's epicardium.The product was used to complete the case.Repair was done during this original surgery.Patient status is recovering and additional procedures for stents and tavr are planned.Additional information provided: original case scheduled was cabg x 4 with avr.Surgeon only completed lima to lad.

• Brand Name: URCHIN EVO HEART POSITIONER
• Common Device Name: STABILIZER,HEART
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 8173623
• Report Number: 2184009-2018-00045
• Device Sequence Number: 19253485
• Product Code: MWS
• UDI-Device Identifier: 00613994533395
• UDI-Public: 00613994533395
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 12/18/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: HP3500
• Device Catalogue Number: HP3500
• Device Lot Number: 2017081198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2018
• Initial Report FDA Received Date: 12/18/2018
• 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
• Patient Age: 73 YR
• Patient Weight: 97