MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION DESTINATION PERIPHERAL GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device not implanted.Explanted date: device not explanted.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported that the doctor was performing a right leg intervention from the left common femoral artery access.15 minutes into the procedure, after the destination sheath is in place, the doctor noticed that the sheath was compromised.The sheath seemed to provide no support.He then decided to remove the sheath.He was able to successfully remove all of the sheath; however, it came out in pieces.The shaft of the sheath was further examined on the back table and it appeared as if the sheath was broken into three pieces and the inner construction was detached from the green outer layer of the sheath.There was no patient harm as a result of this issue.The patient was reported to be in stable condition.The procedure outcome was successful.Additional information was received on 28oct2020.An abbott balloon of an unknown balloon size was used with the reported product.
Event or Problem Description
Additional information was received on 15dec2020.The sheath was compromised due to it breaking apart.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in section b5 and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint can be confirmed for sheath catheter mechanical separation.Based on the information given, the exact root cause of the event cannot be determined.There is no indication that any manufacturing, design or quality system issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• Brand Name: DESTINATION PERIPHERAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 10870900
• Report Number: 1118880-2020-00292
• Device Sequence Number: 19820849
• Product Code: DYB
• UDI-Device Identifier: 00389701008837
• UDI-Public: 00389701008837
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K172995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 54-64501
• Device Lot Number: YC12
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT BALLOON.