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

Catalog Number 5MAXJETDKIT

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

Patient Problem No Patient Involvement (2645)

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.Additional 510(k) #s that also apply to this complaint:k133317.

Event Description

During preparation for a thrombectomy procedure, the physician noticed that a penumbra system jetd reperfusion catheter was broken at the hub upon removal from the penumbra system jetd kit packaging.It was reported that it seemed like the jetd was stuck in the hub and broke when it was pulled out.The damage to the jetd was found prior to use and therefore, it was not used in the procedure.The procedure was completed using another jetd.

Event Description

During preparation for a thrombectomy procedure, the physician noticed that a penumbra system jetd reperfusion catheter was broken upon removal from the penumbra system jetd kit packaging.It was reported that it seemed like the jetd was stuck in the packaging and broke when it was pulled out.The damage to the jetd was found prior to use and therefore, it was not used in the procedure.The procedure was completed using another jetd.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: describe event or problem.Results: the returned jetd was fractured at approximately 70.0 cm from the hub.The device was kinked at approximately 92.0 cm from the hub.The reported complaint did not involve device functionality; therefore, no functional testing was performed.Conclusions: evaluation of the returned jetd confirmed a fractured device.If the packaging lid is not removed from the tray prior to removal of the jetd, the device may become stuck.If the device is then forcefully retracted, it will likely become damaged.Further evaluation revealed a kink on the device.This kink may have been due to the same retraction against resistance or 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 JETD REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8298605
• MDR Text Key: 134880409
• Report Number: 3005168196-2019-00177
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019741
• UDI-Public: 00814548019741
• Combination Product (y/n): Y
• PMA/PMN Number: K090752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2021
• Device Catalogue Number: 5MAXJETDKIT
• Device Lot Number: F86362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1