MAUDE Adverse Event Report: NEOMETRICS, INC.; GUIDEWIRE FROM MINI ACCESS KIT 4 FR SS GUIDEWIRE ECHO

Catalog Number	DYNJMAST07
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during left heart catheterization, the guidewire (taken from custom cardiac cath pack) sheared off subcutaneously into the patient's right groin.After introducer needle was successfully placed in the patient's right groin, the guidewire reportedly would not advance without resistance.Several unidentified number of attempts were made to advance the guidewire through the introducer needle until the physician simultaneously removed both the guidewire and introducer needle and found the tip of the guidewire stretched and sheared.Reportedly, the guidewire was inspected before use and was found defect free by appearance.The patient was reportedly admitted for overnight observation to be closely monitored while determining if tip remained intra or extravascular.Ultrasound and ct scan of the affected right groin area were performed.Per report, no serious injury was identified and patient followed up with the physician twice on outpatient basis with the patient reporting she is feeling well.Due to the reported need for overnight observation and follow-up care, this medwatch is being filed.The sample is not available to be returned for evaluation.The manufacturer of the guidewire was notified of the reported event.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the guidewire (taken from custom cardiac cath pack)) sheared off subcutaneously into the patient's right groin.

• Common Device Name: GUIDEWIRE FROM MINI ACCESS KIT 4 FR SS GUIDEWIRE ECHO
• Manufacturer (Section D): NEOMETRICS, INC.; 2605 fernbrook lane north, sui; plymouth MN 55447
• MDR Report Key: 7922425
• Report Number: 1423395-2018-00052
• Device Sequence Number: 1936280
• Product Code: OEZ
• UDI-Device Identifier: 10888277586192
• UDI-Public: 10888277586192
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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 Catalogue Number: DYNJMAST07
• Device Lot Number: 18PB0486
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 10/01/2018
• 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
• Patient Age: 62 YR
• Patient Weight: 119