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

Catalog Number	PSC054-B
Medical Device Problem Codes	Break (1069); Aspiration Issue (2883)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2016-01121.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using penumbra system 5max reperfusion catheters (5max).During the procedure, while using the 5max to aspirate thrombus, the physician noticed that the aspiration was not working and decided to remove the 5max.After removal of the 5max, the physician noticed that the mid shaft of the 5max was broken.The physician then continued the procedure by using a new 5max; however, the same issue occurred.After removal of the second 5max, the physician noticed that the distal shaft was broken.Therefore, the procedure was completed using another manufacturer's device.It should be noted that the physician did not encounter any resistance while using both 5max devices.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the first penumbra system 5max reperfusion catheter (5max) evaluated was ovalized in multiple locations along its length.The second 5max evaluated was ovalized approximately 60.0 and 130.0 cm from the hub and fractured 123.0, 124.0, and 126.0 cm from the hub.Conclusion: evaluation of the returned devices revealed both 5maxs were ovalized and the second 5max evaluated was fractured.Although the physician reported no resistance was felt while retracting the 5maxs, these types of ovalizations and fractures typically occur as a result of retracting the device against resistance.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5848440
• Report Number: 3005168196-2016-01120
• Device Sequence Number: 446874
• Product Code: NRY
• UDI-Device Identifier: 00814548012742
• UDI-Public: 00814548012742
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2016

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
• Operator of Device: Physician
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: PSC054-B
• Device Lot Number: F63785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2016
• Supplement Report FDA Received Date: 09/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR