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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The user facility reported that the destination sheath broken at the hub before usage.There were no complications, the product was not used.There were no other device or equipment used with the reported product.Additional information was received on 09 dec 2019.The procedure for patient was peripheral intervention.The issue was resolved to continue the procedure as intended, by exchanging for a new sheath.The patient's condition was stable.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One 45 cm 7fr destination sheath and dilator were received for product evaluation.Visual inspection of the sheath revealed damage at the tip of the sheath.The sheath tip was observed under microscope and the tip of the sheath was partially collapsed.The dilator was viewed under microscope and there were two dents on the tip.The dilator tip was viewed under microscope and confirmed to be damaged.The sheath od measured 0.1218 inches which was within manufacturer specifications.The dilator od measured 0.0962 inches which was within manufacturer specifications.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RENAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 9502631
• Report Number: 1118880-2019-00360
• Device Sequence Number: 11248363
• Product Code: DYB
• UDI-Device Identifier: 00389701006192
• UDI-Public: 00389701006192
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K012854
• 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): 12/20/2019

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: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: RSR04
• Device Lot Number: XE03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 104