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

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/23/2020
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.This report is for the second device reported, for the first device reported that was used on the same patient see mdr 1118880-2020-00169.
Event or Problem Description
The user facility reported that the doctor was performing a percutaneous transluminal angioplasty (pta) /atherectomy.When he tried to advance the destination sheath, he noticed the misshaped tip that was preventing him from advancing.He removed the sheath and grabbed another destination and completed the case successfully.The patient was fine after the procedure.The procedure was successful.The blood loss was less than 250cc's.There was no patient injury, medical/surgical intervention required.Additional information was received on 06aug2020: it was reported that there were two sheaths that had the damage occur during an attempt to advance, there was a skin nick made with a blade.They were unable to advance and said that they had an issue with the sheaths.They were eventually able to advance a third sheath.Additional information was received on 07aug2020: blood loss was less than 30ml's.The procedure was successful with the third destination sheath and it was able to be advanced.The patient condition was as expected.The procedure was a percutaneous transluminal angioplasty (pta)/atherectomy of right sfa (superficial femoral artery).
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 8 fr 45 cm destination sheaths were received for evaluation.The components were mated when received.Visual inspection revealed damage at the distal end of the sheath.Microscopy confirmed that the soft tip of the sheath had wrinkles.There was a bulge on the shaft, right above the soft tip.No other visual anomalies were noted.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results it is likely that that the sheath may have encountered some resistance upon insertion.This may be due to an off- centered angle during insertion that propagated forces in different directions.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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: 10463644
• Report Number: 1118880-2020-00204
• Device Sequence Number: 2567780
• Product Code: DYB
• UDI-Device Identifier: 00389701009414
• UDI-Public: 00389701009414
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 54-84501
• Device Lot Number: XF15XP18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 10/06/2020
• 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: WHOLEY WIRE
• Patient Age: 70 YR