MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Catalog Number 3MAXC

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.The hospital discarded the device.

Event Description

During preparation for a thrombectomy, the physician placed a non-penumbra bleedback control valve on the proximal end of a penumbra system ace 68 reperfusion catheter (ace 68) and attempted to advance a penumbra system 3max reperfusion catheter (3maxc) through the ace68; however, the 3maxc broke where its shaft tapers from 4.7 to 3.8f.The 3maxc broke prior to use and therefore, was not used in the procedure.The procedure was completed using a new 3maxc, the same non-penumbra bleedback control valve and the same ace68.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6958599
• MDR Text Key: 90556449
• Report Number: 3005168196-2017-01803
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 3MAXC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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