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

Catalog Number	PTMC-26
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	09/05/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The facility discarded the inoue balloon catheter used in this patient, therefore it is impossible to investigate it anymore.We investigated the manufacturing record of the lot used in this patient and we have confirmed that there was nothing wrong in the manufacturing record.We judged that this event is not caused by manufacturing process based on the investigation of manufacturing record.Instructions for use have already mentioned about this event.Considering the above, we have judged that it is not necessary to take any corrective actions.
Event or Problem Description
Left atrial appendage laceration with secondary cardiac tamponade requiring emergency surgery to correct.Valve anatomy was deemed suitable for commissurotomy but large left atrium with high degree of atrial septal deviation noted.Transseptal puncture completed at 3.7cm height without incident.Wire introduced, septum dilated twice and device advanced over the wire.Septal crossing, and systematic advance around atrium and above mitral valve also unremarkable.Guide wire and stretching tube removed stylet introduced.Several attempts to cross mitral valve were unsuccessful, always lying over posterior aspect of valve, unable to obtain adequate angle to cross mitral valve.Wire reintroduced again and device repositioned, again multiple attempts unsuccessful.Wire reintroduced and device advanced retrograde direction over wire (the loop method) to gain better angle on mitral valve, this was also unsuccessful due to large size of atrium, device would not maintain retrograde orientation.Wire reintroduced and device advanced to mitral valve again, after several unsuccessful attempts an effusion was noted at left atrium/left ventricle area of pericardium.Case was aborted due to velocity of blood loss, patient underwent pericardiocentesis and blood transfusion, always deemed stable throughout.Inoue balloon retrieved intact prior to transport to surgery.The patient taken to main operating room for emergency surgery to correct atrial wall/possible appendage defect.The patient did not survive the surgery.There is no complaint of device problem.

• 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: 7911209
• Report Number: 9612812-2018-00002
• Device Sequence Number: 19297621
• Product Code: MAD
• UDI-Device Identifier: 14960685200030
• UDI-Public: 14960685200030
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2020
• Device Catalogue Number: PTMC-26
• Device Lot Number: 180123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/26/2018
• 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: Death; Required Intervention
• Patient Age: 80 YR