MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not implanted.The actual device has been returned to the manufacturing facility 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 upon removal of the destination slender, it was very difficult to extract, however, was ultimately able to remove the destination slender.It was a left radial access, angiogram, and it was decided to treat the patient's superficial femoral artery (sfa) with diamondback atherectomy, percutaneous transluminal angioplasty (pta) balloon, which was successful.The procedure outcome was successful, and the patient recovered and was in stable condition.Due to extraction, the destination slender has stretched some.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation.One 149 cm r2p device was received for product evaluation.The dilator was returned with the sheath.The sheath and dilator were subjected to visual analysis.There were no gross anomalies noted with the dilator.There was apparent shaft damage and unraveling of the sheath.The first kink was present 16 cm from the distal tip.There was a flattened stretched out section of the sheath 57.5cm from the distal tip.The flattened section persisted for 2 cm.The next damaged section showed an unraveling section that persisted for 3.5 cm.There was a second kink 2 cm distal to this section.The third kink was found approximately 1 cm from the proximal hub.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation of the returned sample, it is likely that tensile forces contributed to the damage that was observed.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 7859368
• Report Number: 1118880-2018-00112
• Device Sequence Number: 19167069
• Product Code: DYB
• UDI-Device Identifier: 00389701011561
• UDI-Public: 00389701011561
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171491
• 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): 09/10/2018

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: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C15W
• Device Lot Number: WD28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: DIAMONDBACK ATHERECTOMY SYSTEM; PTA BALLOON
• Patient Age: 70 YR
• Patient Weight: 56