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

Model Number	N/A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mplanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, investigation conclusions code has been referenced.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 procedure was a left brachial approach to address in-stent brachial restenosis and then to proceed with a right superficial femoral artery (sfa) intervention.They reported that the destination sheath would not cross.Other devices used for the procedure included a pinnacle sheath, glidewire advantage, 149cm destination slender, laser spectranetics, nanaocoss 5 x 100, 6 x 80 balloons, and a 6 x 80 evercross stent.The estimated blood loss was less than 250cc.The patient was in stable condition.The procedure was a technical success.Additional information was received on 12mar2021.When they had difficulty with crossing, they resolved to continue by using a destination slender 149cm sheath as a replacement to cross.The issue was the severe in-stent restenosis (isr) and small stent diameter.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 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 cannot be confirmed for sheath catheter insertion difficulties since the sample was not received.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: 11587069
• Report Number: 1118880-2021-00052
• Device Sequence Number: 19907704
• Product Code: DYB
• UDI-Device Identifier: 00389701008912
• UDI-Public: 00389701008912
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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: 02/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 54-54501
• Device Lot Number: VL20
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 05/05/2021
• 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: 149CM DESTINATION SLENDER; 6 X 80 BALLOONS; 6 X 80 EVERCROSS STENT; GLIDEWIRE ADVANTAGE; LASER SPECTRANETICS; NANAOCOSS 5 X 100; PINNACLE SHEATH
• Patient Weight: 40