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	05/29/2019
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.
Event or Problem Description
The user facility reported that when the physician was performing a lower extremity angio with intervention and stent placement they attempted to remove the destination sheath from the femoral access site, it was observed that the sheath was breaking in two places.The physician then inserted a cook sheath g56220 to help support the removal.Both sheaths were removed and confirmed that the destination sheath had separation in two spots.A new sheath was inserted, and an abbott omnilink stent was placed without incident.The patient was not affected, and the case was completed without incident.
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 7fr destination device along with the dilator was returned for evaluation.Visual inspection revealed that the sheath broke in two sections, 5 cm from the tip and also in the middle of the sheath.The wire was unraveled in these two sections and was exposed as seen in microscopic pictures.The destination sheath was mated with a non-terumo device as seen in the pictures.The dilator was kinked at the tip.No other anomalies were noted with the returned device.Functional testing was performed.The length of the coated area was measured to be 5 cm, and it was noted that the breakage occurred right after this section and the second breakage occurred in a non-coated section as well.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: 8736579
• Report Number: 1118880-2019-00145
• Device Sequence Number: 16669791
• Product Code: DYB
• UDI-Device Identifier: 00389701006192
• UDI-Public: 00389701006192
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: RSR04
• Device Lot Number: WM24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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: COOK SHEATH G56220; STIFF GLIDE; COOK SHEATH G56220; STIFF GLIDE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 60