MAUDE Adverse Event Report: PERFUSION SYSTEMS SUCTION 12118 LV VENT 18FR PVC 20PK 17L; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS

Model Number	12118
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Perforation (2511)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has not been received by medtronic and the investigation is in progress.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Should the product be returned, additional information received, or if the completed investigation yields new information, a follow up report will be submitted.
Event or Problem Description
Medtronic received information that during cannulation, the cannula was placed through the atrial septum and perforated the posterior wall of the left atrium of the heart.The surgeon sutured the wall of the atrium.There were no further adverse patient effects.
Additional Manufacturer Narrative
The device is not available for analysis because it was discarded by the customer.Without the return of the product, no definitive conclusion can be made regarding the clinical observation in this event.The device history record was reviewed and showed this product met all manufacturing specifications for product released for distribution.No issues were identified in the device history record that would have contributed to this event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during cannulation, the cannula was placed through the atrial septum and perforated the posterior wall of the left atrium of the heart.The surgeon sutured the wall of the atrium.There were no further adverse patient effects.

• Brand Name: SUCTION 12118 LV VENT 18FR PVC 20PK 17L
• Common Device Name: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 6696295
• Report Number: 2184009-2017-00024
• Device Sequence Number: 880746
• Product Code: DTS
• UDI-Device Identifier: 20643169086702
• UDI-Public: 20643169086702
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K834352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2017

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: 08/31/2019
• Device Model Number: 12118
• Device Catalogue Number: 12118
• Device Lot Number: 2016081208
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 07/09/2017
• Supplement Report FDA Received Date: 09/13/2017
• 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: 61 YR