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

Model Number	5MAXJETDKIT
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2020
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.Additional 510(k)# that also apply to this complaint: (b)(4).
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the distal m1 and m2 segment of the middle cerebral artery (mca) using a penumbra system jetd reperfusion catheter (jetd), neuron select catheter 6f (6f select), non-penumbra sheath, 071¿ aspiration catheter, non-penumbra catheter, guide catheter and non-penumbra microcatheter.It was noted that the patient¿s anatomy was tortuous in the cavernous segment.During the procedure, the physician accessed the right internal carotid artery using the 6f select and infinity.The physician completed the first pass in the m1 using the aspiration catheter with the non-penumbra catheter and non-penumbra microcatheter as a co-axial setup.The aspiration catheter was then removed and a second pass was completed using the same catheter and microcatheter with aspiration in the m2.The physician removed the non-penumbra catheter and noticed the inferior m2 division was still occluded.Subsequently, the physician attempted to make the third pass using the jetd; however, resistance was encountered while advancing the jetd through the cavernous segment.Consequently, the jetd became kinked approximately one centimeter from the distal tip and was not able to advance or be retracted.Upon manipulation, the physician was able to remove the jetd.The procedure was completed using the same non-penumbra catheter, microcatheter and sheath resulting in thrombolysis in cerebral infarction (tici) 2c.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 3005168196-2020-01374.Results: the jetd was ovalized approximately 22.0 ¿ 23.0, 115.0 and 128.0 ¿ 129.0 cm from the hub.The device was kinked approximately 122.5 cm from the hub.Conclusions: evaluation of the returned jetd revealed ovalizations and a kink on the distal shaft.If the device is manipulated against resistance or is otherwise manipulated at extreme angles during use, damage such as this may occur.During functional testing, the jetd was advanced through a demonstration neuron max without an issue.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the distal m1 and m2 segment of the middle cerebral artery (mca) using a penumbra system jetd reperfusion catheter (jetd), neuron select catheter 6f (6f select), non-penumbra sheath, 071¿ aspiration catheter, non-penumbra catheter, guide catheter and non-penumbra microcatheter.It was noted that the patient¿s anatomy was tortuous in the cavernous segment.During the procedure, the physician accessed the right internal carotid artery using the 6f select and non-penumbra sheath.The physician completed the first pass in the m1 using the aspiration catheter with the non-penumbra catheter and non-penumbra microcatheter as a co-axial setup.The aspiration catheter was then removed, and a second pass was completed using the same non-penumbra catheter and non-penumbra microcatheter with aspiration in the m2.The physician removed the non-penumbra catheter and noticed the inferior m2 division was still occluded.Subsequently, the physician attempted to make the third pass using the jetd; however, resistance was encountered while advancing the jetd through the cavernous segment.Consequently, the jetd became kinked approximately one centimeter from the distal tip and was not able to advance or be retracted.Upon manipulation, the physician was able to remove the jetd.The procedure was completed using the same catheter, microcatheter and sheath resulting in thrombolysis in cerebral infarction (tici) 2c.There was no report of an adverse effect to the patient.

• 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: 10494898
• Report Number: 3005168196-2020-01374
• Device Sequence Number: 16804972
• Product Code: NRY
• UDI-Device Identifier: 00814548019802
• UDI-Public: 00814548019802
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K090752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020
• 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: 01/16/2023
• Device Model Number: 5MAXJETDKIT
• Device Catalogue Number: 5MAXJETDKIT
• Device Lot Number: F95652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Date Report Sent to FDA: 01/01/2005