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 Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been 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.This report is for the first device reported, for the second device reported that was used on the same patient.
Event or Problem Description
The user facility reported the destination device had multiple kinks/smashed.The patient condition was good.The outcome of the procedure was good.There was no patient injury, medical/surgical intervention required.Additional information was received on 26june2020: the type of the procedure was a peripheral leg case.The procedure was completed using another destination.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information to the b5 section, to update section h3, and to provide the completed investigation results.One used 6fr 65 cm destination sheath and dilator was received for product evaluation.The dilator was not mated to the sheath when received.Visual inspection revealed two flattened portions observed on the sheath.Measurements of the first flattened segment was found to be starting at 24.5 cm and ended at 27.3 cm from the hub.The second flattened segment started at 33 cm and ended at 35.2 cm from hub.No other visual anomalies were observed.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.However, the exact cause of the reported event cannot be definitively determined based on the available information.
Event or Problem Description
Additional information was received on 07august2020: when the wire was fed into the sheath during preparation, that was when they noticed the flattened portion.He took another sheath and found that it was also damaged.

• Brand Name: DESTINATION PERIPHERAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• MDR Report Key: 10292513
• Report Number: 1118880-2020-00173
• Device Sequence Number: 10965538
• Product Code: DYB
• UDI-Device Identifier: 00389701007786
• UDI-Public: 00389701007786
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2020

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: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: RSP01
• Device Lot Number: XK21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1