MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION GLIDESHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Patient sex requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation - quality improvement coordinator ll.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.
Event or Problem Description
Terumo medical received a user facility medwatch report # (b)(4).The event description states: "during a cardiac catheterization, the proceduralist attempted to advance the catheter via the left femoral artery, but the aortic valve did not open sufficiently to allow the catheter to enter further.The catheter was removed, and instead a different catheter was advanced to the ascending aorta.Following the catheterization, a curvilinear foreign object near the left femoral head/neck area was seen on radiograph and is suspected to be a wire tip from the glidesheath guidewire." the original intended procedure was a left heart catheterization via left femoral artery.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update sections e4 and g2, maude report (b)(4) is being provided.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record of the product code/lot# combination was conducted with no findings.The complaint can be confirmed for mechanical separation based on the severity of the allegation.Based on the information given, the exact root cause of the event cannot be determined.There is no indication that any manufacturing, design or quality system issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• Brand Name: GLIDESHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 12056639
• Report Number: 1118880-2021-00146
• Device Sequence Number: 3775032
• Product Code: DYB
• UDI-Device Identifier: 00389701009926
• UDI-Public: 00389701009926
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2021

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: 02/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 15-1050
• Device Lot Number: 0000004443
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 07/24/2021; 07/21/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 07/09/2021; 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other