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

Model Number	5MAXJETDKIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional 510(k) # that also applies to this complaint: (b)(4).This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (mca) using a penumbra system jetd reperfusion catheter (jetd), neuron max 6f 088 long sheath (neuron max), guidewire (terumo), non-penumbra catheter (sophia 6fr), and penumbra system 3max reperfusion catheter (3maxc).During the procedure, the physician gained access using the neuron max and guidewire.The physician removed clot in the m1 segment of the mca using a 6fr sophia with aspiration.The sophia catheter was then removed and a jetd with 3maxc were placed in the m2.The physician then initiated aspiration with the 3maxc to remove clot.Subsequently, the 3maxc was removed and the physician injected contrast manually through the jetd with the tip of the jetd in the m1 to confirm the results of the thrombectomy; however, it was noticed the jetd had broken into two pieces.Therefore, the physician removed the proximal segment.The physician used a snare device to remove the broken distal segment of the jetd.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned jetd confirmed that the catheter was fractured.This damage typically occurs due to retraction against resistance.Additionally, the jetd is not indicated for contrast injection.Further evaluation revealed an ovalization on the proximal end of the distal fractured segment.This damage likely occurred while snaring the device during removal from the patient and was incidental to the reported complaint.Penumbra catheters are visually 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
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11334460
• Report Number: 3005168196-2021-00286
• Device Sequence Number: 16349531
• Product Code: NRY
• UDI-Device Identifier: 00814548019802
• UDI-Public: 00814548019802
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• 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): 01/17/2021
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2023
• Device Model Number: 5MAXJETDKIT
• Device Catalogue Number: 5MAXJETDKIT
• Device Lot Number: F96762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/17/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 75
• Date Report Sent to FDA: 01/01/2005