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

Catalog Number	PSC054-B
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the first penumbra system 5max reperfusion catheters (5max) evaluated was ovalized approximately 24.0 cm from the hub.Conclusions: evaluation of the first 5max revealed that it was ovalized.This type of damage typically occurs due to improper handling during use.If the device is manipulated or gripped with force during use, damage such as this may occur.Evaluation of the second 5max revealed that it was kinked.This type of damage typically occurs due to improper handling during use.If the device is forcefully advanced against resistance damage such as this may occur.The neuron max mentioned in the complaint was not returned for evaluation, and the root cause of the initial resistance experienced by the physician could not be determined.All 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.This report is associated with mfr report number: 3005168196-2016-01330.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using penumbra system 5max reperfusion catheters (5max).During the procedure, the first 5max was used with a neuron 6f 088 long sheath (neuron max) for aspiration.The physician then retracted the 5max to do a pass using a stent retriever and noticed that the 5max was kinked.Therefore, the physician continued the procedure with a new 5max.While advancing the second 5max, the physician experienced resistance and suspected that the 5max had become kinked.Therefore, the 5max was removed and was confirmed to be kinked upon inspection.The procedure was then completed using a third 5max and the same neuron max.There was no report of an adverse effect to the patient.

• 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: 5958040
• Report Number: 3005168196-2016-01329
• Device Sequence Number: 16623611
• Product Code: NRY
• UDI-Device Identifier: 00814548012742
• UDI-Public: 00814548012742
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2016

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: 03/08/2019
• Device Catalogue Number: PSC054-B
• Device Lot Number: F68308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2016
• Initial 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: 85 YR