MAUDE Adverse Event Report: PENUMBRA, INC. RED 72; CATHETER, THROMBUS RETRIEVER

Model Number RED72KIT-A

Device Problems Break (1069); Material Split, Cut or Torn (4008)

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

Event Date 02/22/2022

Event Type  malfunction  

Event Description

While md was pulling tubing out of the body, part of the tube snapped and split (outside the body) new catheter had to be opened to complete the procedure.No harm to patient harm.Manufacturer response for red 72 aspiration cath, (brand not provided).Device given to field rep for evaluation.

• Brand Name: RED 72
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 13905149
• MDR Text Key: 287927242
• Report Number: 13905149
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RED72KIT-A
• Device Catalogue Number: RED72KIT
• Device Lot Number: F108925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2022
• Date Report to Manufacturer: 03/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32485 DA
• Patient Sex: Female