MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD AMPLATZER SIZING BALLOON II; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	9-SB-034
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	11/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2019, a 34 mm amplatzer sizing balloon ii was selected for use.During the procedure, a pericardial effusion was noted.At the end of the procedure, a pericardiocentesis was performed and the patient was transferred to surgery where no leak was found.The patient was stable before, during, and after the issue.The cause of the pericardial effusion is not clear.The patient is stable post-operatively.
Additional Manufacturer Narrative
An event of pericardial effusion was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
On (b)(6) 2019, a 34mm amplatzer sizing balloon ii was selected for use.During the procedure, a pericardial effusion was noted.At the end of the procedure, a pericardiocentesis was performed and the patient was transferred to surgery where no leak was found.The patient was stable before, during, and after the issue.The cause of the pericardial effusion is not clear.The patient is stable post-operatively.

• Brand Name: AMPLATZER SIZING BALLOON II
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9410256
• Report Number: 2135147-2019-00387
• Device Sequence Number: 17194007
• Product Code: MJN
• UDI-Device Identifier: 00811806011530
• UDI-Public: 00811806011530
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K053440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2020

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: 02/28/2022
• Device Model Number: 9-SB-034
• Device Catalogue Number: 9-SB-034
• Device Lot Number: 6896460
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 12/07/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/02/2020
• 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