MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER; NRY

Catalog Number 5MAXACE132

Device Problems Cut In Material (2454); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system 5max ace reperfusion catheter (5max ace) was fractured underneath the strain relief approximately 1.0 cm from the hub.Conclusions: evaluation of the returned device revealed it was fractured under the strain relief.This type of damage typically occurs due to improper handling during removal from the packaging or preparation.If the catheter is manipulated forcefully at an angle during removal from the packaging hoop or preparation, the proximal shaft may fracture due to excess force and bending.These devices are 100% visually evaluated during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system 5max ace reperfusion catheter (5max ace).During the procedure, while in use with other manufacturer's devices, the physician initiated aspiration and noticed that the 5max ace was leaking blood from a slit located distal to the hub.The physician removed the 5max ace and successfully completed the procedure using another manufacturer's catheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5339076
• MDR Text Key: 34884762
• Report Number: 3005168196-2015-01370
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012803
• UDI-Public: 00814548012803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F62955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2015
• 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 Age: 75 YR
• Patient Weight: 82