MAUDE Adverse Event Report: PENUMBRA INC. PENUMBRA INDIGO SYSTEM ASPIRATION TUBING; CORONARY MECHANICAL THROMBECTOMY WITH ASPIRATION

Catalog Number CATRXKIT

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

Event Date 11/07/2023

Event Type  malfunction  

Event Description

The patient was in the cath lab for a right lower extremity thrombectomy with penumbra device; towards the end of the case the penumbra catheter broke into two pieces outside of the patients body and outside of the sheath; a wire was inserted into the catheter and the penumbra catheter was removed intact without harm to the patient; all other equipment was removed from patient and case was ended at this time.

• Brand Name: PENUMBRA INDIGO SYSTEM ASPIRATION TUBING
• Type of Device: CORONARY MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): PENUMBRA INC.; alameda CA 94502
• MDR Report Key: 18131067
• MDR Text Key: 328229752
• Report Number: MW5148086
• Device Sequence Number: 1
• Product Code: QEX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/08/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F112163
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: White