MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SIZING BALLOON II; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	9-SB-018
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Heart Failure (2206)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of hemodynamic compromise and reduced right ventricle compression after the sizing balloon was decompressed 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.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the instruction for use, artmt100092312 revision a " this device was sterilized with ethylene oxide and is for single use only.Do not reuse or resterilize this device.".
Event or Problem Description
On (b)(6) 2020, a 12/10mm amplatzer duct occluder was selected for implant using a 7f amplatzer torqvue delivery system (ds) to close a fistula, aware this is an off-label use.However, the occluder was not released because it did not remain seated when tugged.The device was removed from the patient and the physician decided to re-measure the fistula with an 18mm amplatzer sizing balloon.The fistula measured about 14mm and the sizing balloon was decompressed.However, the patient became severely hemodynamically compromised and had reduced right ventricle compression.The sizing balloon was re-inserted and re-inflated to block the shunt and the patient regained hemodynamic stability.A 16mm amplatzer muscular vsd occluder was selected for implant using a 9f amplatzer torqvue ds to close the fistula; the physician is aware this is off-label use.There was significant resistance when inserting the delivery sheath.The 16mm occluder was successfully implanted.The patient was hemodynamically stable at the end of the procedure and moved to the ccu for observation.The patient is reportedly stable.

• Brand Name: AMPLATZER SIZING BALLOON II
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9751489
• Report Number: 2135147-2020-00046
• Device Sequence Number: 743130
• Product Code: MJN
• UDI-Device Identifier: 00811806011516
• UDI-Public: 00811806011516
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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-018
• Device Catalogue Number: 9-SB-018
• Device Lot Number: 6922464
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/25/2020
• 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
• Patient Age: 47 YR