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

Catalog Number	5MAXJETDKIT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 510(k) # that also applies to this complaint: k133317.Results: the returned penumbra system jetd reperfusion catheter (jetd) was kinked at approximately 32.0 cm and 129.0 cm from the hub.The device was ovalized at approximately 20.0 cm from the hub.Conclusions: evaluation of the returned 3maxc confirmed stretching on the distal shaft.There was also a catheter break on this stretched region.If the device is forcefully retracted against resistance, the device may stretch.If the device continues to be retracted against resistance, it may become fractured.Evaluation of the returned jetd revealed a kink on the distal shaft.This kink likely contributed to the resistance and subsequent stretching experienced during the procedure while retracting the penumbra system 3max reperfusion catheter (3maxc).Further investigation revealed jetd had an additional kink and an ovalization on the catheter.These damages were likely incidental to the complaint.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: 3005168196-2019-00880.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m2 of the left middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc).During the procedure, the physician advanced a penumbra system jetd reperfusion catheter (jetd) over the 3maxc with a guidewire to the target location.It was reported that the patient¿s vessels were very tortuous.The physician then attempted to retract and remove the 3maxc, however, the physician felt resistance.Therefore, the physician retracted the jetd to release tension and was then able to remove the 3maxc and the guidewire.However, upon removal, the physician found that the 3maxc was stretched.The procedure was able to be completed with one pass of the jetd.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: 8777034
• Report Number: 3005168196-2019-01338
• Device Sequence Number: 1977510
• Product Code: NRY
• UDI-Device Identifier: 00814548019741
• UDI-Public: 00814548019741
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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
• Report Date (Section B): 04/05/2019
• 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: 12/18/2021
• Device Catalogue Number: 5MAXJETDKIT
• Device Lot Number: F87582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 98
• Date Report Sent to FDA: 01/01/2005