MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD VARADY PHLEB LGE HK/SPATU 7 IN DE EXTRACTOR; JARIT

Catalog Number X21417

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

The varady phleb lge hk/spatu 7 in de extractor (x21417) was not returned for evaluation, as the customer stated the product was disposed of.Lot number was provided, device history record (dhr) was reviewed, and no abnormalities related to the reported issue were identified.Customer provided a photo of the instrument.Per the provided image, it was determined that the tip breakage may have resulted from environmental damage or rough handling.However, a definitive root cause cannot be determined without return of the actual product for evaluation.No manufacturing, workmanship or material deficiency has been identified.

Event Description

A facility reported that the tip of the varady phleb lge hk/spatu 7 in de extractor (x21417) broke off in a patient while pulling on a vein, during vascular surgery.An x-ray was taken to retrieve the broken part.It was reported that the patient was in good condition.Another device was available for use.There was a delay in surgery of approximately 20-30 minutes.

• Brand Name: VARADY PHLEB LGE HK/SPATU 7 IN DE EXTRACTOR
• Type of Device: JARIT
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18312368
• MDR Text Key: 330680480
• Report Number: 3014334038-2023-00185
• Device Sequence Number: 1
• Product Code: GAI
• UDI-Device Identifier: 10381780373582
• UDI-Public: 10381780373582
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Catalogue Number: X21417
• Device Lot Number: AC2306
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2023
• Date Device Manufactured: 06/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1