MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS CALYPSO; BCP ¿ SOFT TISSUE 17G

Model Number HCL1060

Device Problem Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/07/2023

Event Type  Injury  

Manufacturer Narrative

The customer was expecting to insert an introducer into the patient and release a transponder.However, the customer reported that the introducers broke off in the patient and part of the introducer was unable to be retrieved.The investigation confirmed the issue did occur.The introducer broke 5 cm from the introducer tip which does not coincide with the end of the stylet when the stylet is correctly inserted and clip attached (end of stylet about 2 cm from tip).Each needle part shows a narrowing at the point of breakage.This kind of narrowing is expected when a tubing is kinked.It was determined that the user unintentionally kinked the introducer while the stylet was not inserted or not fully inserted.Investigation of the returned device shows that there are narrowing's at the point of breakage which result from previous kinking.This kinking resulted in subsequent breakage.No corrective action is needed because the ifu does provide adequate instructions for use and introducer kinking is covered including warning to not use a damaged introducer.When the issue occurs the user will notice issues during stylet insertion into the affected position.The ifu lbl0258-002 adequately describes how to load the deploy the transponder and how to handle a damaged introducer.Should the issue recur in the future the user should follow the ifu and dispose of the damaged introducer.

Event Description

The doctor explained that the calypso needle broke off in the patient during a routine calypso procedure.There is approximately 2 cm that was unable to be retrieved from the patient.The hospital informed that the patient has had the piece removed successfully.So far there are no complications.The affected device was sent by the customer for investigation.

• Brand Name: CALYPSO
• Type of Device: BCP ¿ SOFT TISSUE 17G
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; 911 hansen way; palo alto CA 94304
• Manufacturer Contact: nia van baalen ; 911 hansen way; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 17686218
• MDR Text Key: 322697154
• Report Number: 2916710-2023-00003
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00850011006047
• UDI-Public: 00850011006047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152761
• 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: 08/07/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: HCL1060
• Device Lot Number: 0001544563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention