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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.A review of the device history record of the product code/lot# combination was conducted with no findings.One used 8fr 65cm destination sheath and dilator was returned for product evaluation.The dilator was partially mated to the sheath with 8.5 cm of the dilator sticking out.Visual inspection revealed that a few kinks were observed on the sheath.Resistance was experienced when trying to insert the dilator in through the sheath.Measurements of the first kink was found to be starting at 37.5cm from the hub and second kink was observed at 47cm from the hub.No other visual anomalies were observed on the dilator.Dimensional testing was performed.The outer diameter of the sheath was measured to be 0136 in which was within the manufacturer's specifications.The complaint can be confirmed for sheath catheter mechanical damage.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.This report is for the second device reported, for the first device reported that was used on the same patient see mdr 1118880-2021-00084.
Event or Problem Description
The user facility reported that the destination desilet folded, which made it impossible to mount the dilator.This happened with two devices from this lot.A total of three devices were used for this procedure.

• 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: 11745197
• Report Number: 1118880-2021-00085
• Device Sequence Number: 17200068
• Product Code: DYB
• UDI-Device Identifier: 00389701009438
• UDI-Public: 00389701009438
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K172995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 04/29/2021

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: 01/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 54-86501
• Device Lot Number: 0000001972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1