MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION TITAN STABILIZER ATTACHMENT; UNIVERSAL STABILIZER ARM

Model Number	T401231
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the stabilizer's base got fractured when the doctor was adjusting it to attach to the patient.It is unknown if there was a blood loss in the procedure.Due to the unknown information for this event, it is being reported.Terumo continues to attempt to gain more information regarding this event from the user facility.No known impact or consequence to patient.Product was changed out.Procedure was completed successfully.
Event or Problem Description
Additional information received that no blood loss during the procedure.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: b5 (additional event information).D2 (corrected device product code).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information, correction and device evaluation).H3 (device evaluated by manufacturer).H4 (additional device information - added manufacturing date).H6 (identification of evaluation codes 10, 3259, 4307).Method code: 10 - testing of.Results code: 3259 - improper physical structure.Conclusions code: 4307 - cause traced to component failure.The sample was returned, it was confirmed that the shaft was broken at the malleable zone.The malleable zone was measured with micrometers.The measurement was found to be 0.08405", the specification is 0.085 +/- 0.005".This component was within specifications.A bending cycles inspection was unable to be conducted as the malleable zone was broken.The most likely root cause of this failure is over bending the malleable zone past 45° or for more than five cycles as designed.The shaft is intended to be repositioned, but repeated bending or over bending will cause the product to break.A retention sample and a dhr was not able to be reviewed as the lot number was not provided.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on august 20, 2019.Upon further investigation of the reported event, the following information is new and/or changed: a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: d2 (suspected medical device - corrected device product code); g4 (date received by manufacturer) ; g7 (indication that this is a follow-up report) ; h2 (follow-up due to correction).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: TITAN STABILIZER ATTACHMENT
• Common Device Name: UNIVERSAL STABILIZER ARM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8910584
• Report Number: 1124841-2019-00230
• Device Sequence Number: 14145923
• Product Code: MWS
• UDI-Device Identifier: 00699753450554
• UDI-Public: (01)00699753450554
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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,Followup,Followup,Followup
• Report Date (Section B): 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: T401231
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 08/27/2019; 09/12/2019; 03/04/2020
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/12/2019; 09/18/2019; 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1