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

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/26/2019
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 upon insertion of the destination sheath, the physician felt resistance so he removed it.The end of the sheath had frayed, which was causing the resistance.The sheath was retained, and a new one was used without issues.Additional information was received 30august2019: the type of procedure performed was a rle angiogram, poss.Iliac stent and poss.Atherectomy.Another destination sheath was used.The patient was reported to be in stable condition.The blood loss was minimal.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to report that this event has been deemed not reportable based off an internal review.It has been found that this event has been inadvertently reported; however, this event is currently deemed a non-reportable event.

• 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: 9106945
• Report Number: 1118880-2019-00247
• Device Sequence Number: 2062582
• Product Code: DYB
• UDI-Device Identifier: 00389701006185
• UDI-Public: 0389701006185
• 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): 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: RSR03
• Device Lot Number: XA09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 92