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

Catalog Number	5MAXJET7
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the jet7 was partially fractured approximately 52.5 cm from the hub but still intact as one piece.Conclusions: evaluation of the returned jet7 revealed that the catheter shaft was partially fractured near its proximal end.If the device is forcefully retracted against resistance, damage such as this may occur.If the catheter was being retracted at extreme angles outside the patient¿s body, it may have contributed to the damage observed on the returned jet7.Further evaluation revealed the jet7 was still intact as one piece and able to be retracted out of the patient.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 jet7 kit.The patient's anatomy was moderately tortuous.During the procedure, the physician felt resistance while advancing the penumbra system jet 7 reperfusion catheter (jet7) into the target vessel and was unable to reach the clot.The jet7 was therefore retracted.As the jet7 was being retracted, the physician felt resistance and noticed that the jet7 had become stuck in the ophthalmic artery.As the physician continued to retract, the jet7 fractured at the proximal half while still within the patient.The jet7 was therefore removed.The procedure was completed using another catheter.There was no report of an adverse effect to the patient.
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 jet7 kit.The patient's anatomy was moderately tortuous.During the procedure, the physician felt resistance while advancing the penumbra system jet 7 reperfusion catheter (jet7) into the target vessel and was unable to reach the clot.As the jet7 was being retracted, the physician felt resistance and noticed that the jet7 had become stuck near the ophthalmic artery.As the physician continued to retract, the jet7 fractured at the proximal half while still within the patient.The jet7 was therefore removed.The procedure was completed using another catheter.There was no report of an adverse effect to the patient.

• 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: 8219961
• Report Number: 3005168196-2018-02538
• Device Sequence Number: 1630894
• Product Code: NRY
• UDI-Device Identifier: 00814548019901
• UDI-Public: 00814548019901
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 11/26/2018
• 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: 01/10/2021
• Device Catalogue Number: 5MAXJET7
• Device Lot Number: F81391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 01/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 45
• Date Report Sent to FDA: 01/01/2005