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

Model Number	5MAXJET7KIT-B
Medical Device Problem Codes	Stretched (1601); 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	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 m1 of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7) and non-penumbra sheath.It was reported that the patient anatomy was tortuous.During the procedure, the jet7 was placed in the target vessel, and the sheath was advanced around a significant turn and over the jet7.While removing the jet7 after the first pass, the physician experienced tension, and the jet7 was observed to be stretched 15-20cm from the distal tip.Therefore, the jet7 not used for the remainder of the procedure.The procedure was completed using a non-penumbra catheter and the same sheath, resulting in a thrombolysis in cerebral infarction (tici) grade 2b.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the jet7 was stretched approximately 111.0 thru 125.5 cm from the hub.The total length of the returned jet7 was approximately 138.5 cm.Conclusions: evaluation of the returned jet7 confirmed that the distal shaft was stretched.If the jet7 is forcefully retracted against resistance, damage such as stretching may occur.The root cause of resistance could not be determined.During the functional test, resistance was encountered while attempting to advance the returned jet7 through a demonstration neuron max due to the stretched distal shaft, and the jet7 could not be advanced any further.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 JET7 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10951086
• Report Number: 3005168196-2020-02182
• Device Sequence Number: 14058480
• Product Code: NRY
• UDI-Device Identifier: 00815948020962
• UDI-Public: 00815948020962
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190010
• 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): 11/09/2020
• 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: 01/27/2023
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F95873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005