MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET7 REPERFUSION CATHETER; NRY

Model Number	5MAXJET7BKIT-A
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned jet7 confirmed that the catheter was fractured.If the jet7 is forcefully retracted against resistance, damage such as a fracture may occur.The root cause of resistance could not be determined.Evaluation of the returned neuron max revealed no visible damage.During the functional test, a stainless-steel mandrel could not be advanced through the neuron max due to the reported fractured distal shaft of the jet7 inside the lumen.Therefore, the distal shaft of the jet7 could not be removed.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), a neuron max 6f 088 long sheath (neuron max), and a penumbra system 3max reperfusion catheter (3maxc).It was noted that the patient¿s access vessel was calcified.During the procedure, while initially advancing the neuron max through the access vessel, the physician experienced resistance; however, the physician successfully placed the neuron max.Then, while advancing the jet7 through the neuron max, the physician experienced resistance.Subsequently, the physician was unable to advance the jet7 further and decided to remove the jet7.While retracting the jet7, the physician experienced resistance.Subsequently, under fluoroscopy the physician noticed that the distal end of the jet7 was fractured and remained inside the proximal end of the neuron max.Therefore, the jet7 and neuron max were removed together.The procedure was completed using a new neuron max, a penumbra system ace 68 reperfusion catheter (ace68), and the same 3maxc.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility with the following reference number: mw5098817.The following sections are being updated based on additional information included in the user facility report submitted to the fda: 1.Section e.Box 4.Initial reporter also sent report to fda.2.Section g.Box 3.Report source h3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11301496
• Report Number: 3005168196-2021-00242
• Device Sequence Number: 20082754
• Product Code: NRY
• UDI-Device Identifier: 00815948023246
• UDI-Public: 00815948023246
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K173761
• 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): 01/11/2021
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2023
• Device Model Number: 5MAXJET7BKIT-A
• Device Catalogue Number: 5MAXJET7BKIT
• Device Lot Number: C23986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 02/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 90
• Date Report Sent to FDA: 01/01/2005