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

Catalog Number	5MAXJETDKIT
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 510(k)# that also applies to this complaint: k133317.The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-00728.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m2 segment of the left middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc) and a penumbra system jetd reperfusion catheter (jetd) from a penumbra system jetd kit.It should be noted that the patient's anatomy was very tortuous.During the procedure, the physician experienced resistance while manipulating the 3maxc into the target vessel through the jetd and a neuron max 6f 088 long sheath (neuron max).As the physician continued to advance the 3maxc, it was reported that the 3maxc broke at the rhv of the jetd.The physician then clamped the jetd using a kelly clamp and extracted the 3maxc.It was also reported that, upon clamping the jetd, it became crushed.The rhv, 3maxc, and jetd were, therefore, removed from the procedure.The procedure was completed successfully using a velocity delivery microcatheter (velocity), a penumbra system 3d reperfusion catheter (psr3d), a penumbra system 5max reperfusion catheter (5maxc), and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the penumbra system jetd reperfusion catheter (jetd) was fractured at approximately 8.0 cm from the hub.The device had ovalization at approximately 7.0 cm from the hub.Conclusions: evaluation of the returned 3maxc confirmed a fractured device.If the device is advanced through the reported tortuous patient anatomy resistance will encounter.Forcefully advanced against resistance may cause the device to become fractured.Evaluation of the returned jetd revealed an ovalization on the catheter.Based on the reported complaint, this damage was likely a result of forcefully gripping the device with the clamp while retracting from the patient body.Further investigation revealed that the jetd was fractured near the ovalized location.This damage was incidental and could have happened after removing from the patient body.A device malfunction could not be confirmed.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: 3005168196-2019-00728.

• Brand Name: PENUMBRA SYSTEM JETD REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8524708
• Report Number: 3005168196-2019-00729
• Device Sequence Number: 2759094
• Product Code: NRY
• UDI-Device Identifier: 00814548019741
• UDI-Public: 00814548019741
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090752
• 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): 03/18/2019
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 11/20/2021
• Device Catalogue Number: 5MAXJETDKIT
• Device Lot Number: F87142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 84
• Date Report Sent to FDA: 01/01/2005