MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS MINI APICAL CUFF KIT; VENTRICULAR (ASSISST) BYPASS

Model Number	10005877
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that during implant the apical cuff holder was observed to be damaged in 2 spots, out of the box.The surgeon taped the areas that were damaged and continued to use the holder.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: evaluation of the returned apical cuff holder confirmed the reported damage.The center reported that during an implant, the apical cuff holder was observed to be damaged, out of the box.No alarms were reported for this event.The surgeon taped the areas that were broken and continued to use.The apical cuff holding tool, lot number 6822721, was received for evaluation on 26dec2019.Examination of the returned apical cuff holding tool found that the handle was cracked in three locations, approximately 3.25¿, 3.5¿, and 4.25¿ from the luer port end of the tool.The observed cracks extended approximately halfway through the handle diameter.The observed damage appeared consistent with bending of the tool.The device history records for the apical cuff holder lot number 6803652 and apical cuff/tool kit lot number 6822721 were reviewed.No deviations from manufacturing or quality assurance specifications were observed.This process includes visual inspection for physical damage at multiple steps throughout the fabrication process, including qa final review.A duration of time for which the apical cuff holding tool was damaged could not be conclusively determined through this evaluation.Additionally, this issue was forwarded for manufacturing analysis via pi task# pi-2019-0266575-01-01-002.A separate process qualification previously found that moving from 99.5% ipa to 70% ipa for cleaning of the machined straight handle material resulted in a lower cracking rate of that material.A change will be made to the apical cuff holding tool fabrication procedure so that the components of this tool will be cleaned with 70% ipa based on the findings of the previous report.Although a duration of time for which the tool was damaged could not be conclusively determined, as an additional preventive measure, this fabrication procedure will be revised such that the final inspection step prior to sending parts to the cleanroom includes an inspection for part damage along with the existing inspection for foreign material.These revisions will be processed using co-018301.Per the change order process, operator training will take place during co implementation.The hm3 mini apical cuff kit ifu states ¿do not use the device if it appears to be damaged in any way¿.This ifu also contains instructions for preparing the mini apical cuff and apical cuff holder, securing the mini apical cuff to the ventricle, and confirming hemostasis.Incidental findings: evaluation of the returned apical cuff holder confirmed the reported damage.The heartmate 3 mini apical cuff kit ifu (document #10006218, rev.E) is currently available.The surgical procedures section of this ifu states ¿do not use the device if it appears to be damaged in any way¿.This ifu also contains instructions for preparing the mini apical cuff and apical cuff holder, securing the mini apical cuff to the ventricle, and confirming hemostasis.No further information was provided.The manufacturer is closing the file on the event.

• Brand Name: HEARTMATE 3 LVAS MINI APICAL CUFF KIT
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 9526094
• Report Number: 2916596-2019-05977
• Device Sequence Number: 399015
• Product Code: DSQ
• UDI-Device Identifier: 00813024013082
• UDI-Public: 00813024013082
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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 Expiration Date: 01/29/2022
• Device Model Number: 10005877
• Device Catalogue Number: 10005877
• Device Lot Number: 6822721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1