MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER; NRY

Catalog Number	4MAXC
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2016
Type of Reportable Event	Malfunction
Additional 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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital is keeping the device.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra reperfusion 4max reperfusion catheter (4max).During the procedure, the physician attempted to insert the 4max into the rotating hemostasis valve (rhv); however,the 4max would not advance beyond the first few centimeters.Therefore, the physician opened the rhv as large as it could be opened; however the 4max was still unable to advance.The physician reported that the 4max seemed visually a bit large.The procedure was completed using a new penumbra system 4max distal delivery catheter (4maxddc) and the same rhv.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device was initially not available for return; however, the device has been returned and an investigation was completed.Results: the penumbra system 4max reperfusion catheter (4max) was ovalized approximately 94.0 cm from the hub to 104.0 cm from the hub.The 4max was kinked in multiple locations.Conclusions: evaluation of the returned device revealed the od of the distal shaft was within specification.Further evaluation revealed the 4max was ovalized.The damage may have occurred due to forceful handling of the 4max during preparation for use or insertion into an rhv.The ovalization likely prevented the 4max from being advanced through the rhv during the procedure.Further evaluation revealed the 4max had multiple kinks.This damage was likely incidental and may have occurred during packaging for return to penumbra.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 4MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6133838
• Report Number: 3005168196-2016-01735
• Device Sequence Number: 13540605
• Product Code: NRY
• UDI-Device Identifier: 00814548012414
• UDI-Public: 00814548012414
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• 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,Followup
• Report Date (Section B): 11/01/2016

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: 06/30/2018
• Device Catalogue Number: 4MAXC
• Device Lot Number: F64355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2016
• Supplement Report FDA Received Date: 03/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1