MAUDE Adverse Event Report: HERAEUS MEDICAL COMPONENTS MOTION HYBRID WIRE GUIDE; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number MHW- 035150

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/14/2022

Event Type  malfunction  

Event Description

Circulator was informed by surgeon that "a fragment of the hydrophilic tip from the motion hybrid wire guide broke off and was retained in the patient." the surgeon was able to visualize the fragment with the c-arm that was currently being used during the operation.Circulator was informed that the fragment cannot be removed at this time.Circulator notified the charge nurse at the front desk per protocol and completed sos per protocol.The motion hybrid wire guide.035" ref mhw-035150/ref (b)(4), lot 9007112132, expiration 01/27/2024.

• Brand Name: MOTION HYBRID WIRE GUIDE
• Type of Device: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS; 5030 centerville road; st. paul MN 55127
• Manufacturer (Section G): HERAEUS MEDICAL COMPONENTS, SRL; parque industrial zona franca; la lima guadalupe building 29; cartago, costa rica 30106 ; CS 30106
• Manufacturer Contact: tim desaulniers ; 5030 centerville road; st. paul, MN 55127 ; 6123252003
• MDR Report Key: 13685001
• MDR Text Key: 290143205
• Report Number: 3008988055-2022-00001
• Device Sequence Number: 1
• Product Code: EZB
• UDI-Device Identifier: 00827002448469
• UDI-Public: (01)00827002448469(17)240127(10)9007112132
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2024
• Device Model Number: MHW- 035150
• Device Catalogue Number: G44846
• Device Lot Number: 9007112132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Race: White