MAUDE Adverse Event Report: TORAY INDUSTRIES, INC. INOUE BALLOON CATHETER; CATHETER, PERCUTANEOUS (VALVULOPLASTY)

Catalog Number	PTMC-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); Rupture (2208)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As a result of our investigation into the actual device returned from the medical institution, it was found out that the lot no.Was 190124 and there were no problems observed with the manufacturing record or at the time of shipment.No abnormality of the device was detected as a result of the investigation into the returned device.
Event or Problem Description
Patient sustained, what initially appeared to be, a chord rupture after 2nd inflation at 23mm.Septal crossing was in proper location with uncomplicated crossing of mitral valve on both inflation attempts, no empasse sign noted.After inflation severe concentric mr jet noted on echo with temporary drop in patient's pao2.Pt's bp, sats, were stable without additional intervention.Surgical consult completed and patient taken to or for valve replacement.Pt's coronaries were assessed prior to surgery and right main was occluded resulting in a surgical plan of mv replacement, grafting for occlusion, clipping of atrial appendage and ablation for afib.Initial assessment for patient for surgical interventions are good.

• Brand Name: INOUE BALLOON CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS (VALVULOPLASTY)
• Manufacturer (Section D): TORAY INDUSTRIES, INC.; 1-1, nihonbashi-muromachi; 2-chome; chuo-ku, tokyo, 103-8 666; JA 103-8666
• MDR Report Key: 8742091
• Report Number: 9612812-2019-00001
• Device Sequence Number: 2040520
• Product Code: MAD
• UDI-Device Identifier: 14960685200030
• UDI-Public: 14960685200030
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P910054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2019

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: 01/24/2021
• Device Catalogue Number: PTMC-28
• Device Lot Number: 190124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/27/2019
• 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: Life Threatening; Required Intervention
• Patient Age: 58 YR