MAUDE Adverse Event Report: ANGIODYNAMICS XCELA; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	145672
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A director of cardiac and vascular services reported an issue with an xcela 5fdl-55cm ir-145 kit.During placement of the catheter, the peel away sheath broke away from the sheath hub as the picc was being advanced over the guidewire.The sheath became lodged in the patient's body but was able to be retrieved using a snare.The patient did not experience any adverse effects or harm because of this incident.
Additional Manufacturer Narrative
The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
Returned for evaluation was one (1) 5f sheath with tubing detached.As received the returned sheath tubing was detached from the handle.The tubing was also bent in half.The handle is still in one piece, i.E.Not broken open.The customer's reported complaint description of sheath tubing detached from the hub was confirmed based on evaluation of the returned complaint sample.A device history records review of the packaging/introducer lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.(b)(4) and the returned sheath complaint sample was sent to the sheath/dilator supplier/manufacturer (greatbatch) for sample evaluation/root cause determination and dhr review of the reported supplier lots.(b)(4) response states: root cause could not be determined.Analysis of the device provided did not reveal a manufacturing issue and review of the manufacturing records did not reveal any discrepancies that would have contributed to this event.Follow attempt did not clarify the potential root cause of use/handling issue by the end user in the field.The current occurrence rate is within the predicted occurrence rate limits.The complaint part was reviewed under x-ray and it was found that the part does have the holes at the proximal end.The complaint part was compared against a normal production part and the punched holes are present in the tubing and do not show any abnormal condition.Likely root cause is handling damage to device hub during use.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: XCELA
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 19701499
• Report Number: 1317056-2024-00098
• Device Sequence Number: 11666655
• Product Code: LJS
• UDI-Device Identifier: M001456720
• UDI-Public: M001456720
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K070002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: 145672
• Device Catalogue Number: 145672
• Device Lot Number: 5817539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 378 KG