MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER; NRY

Model Number 5MAXJET7KIT-B

Device Problems Stretched (1601); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

Results: the jet7 was kinked and ovalized approximately 110.5 ¿ 112.5 cm from the hub.The total length of the jet7 was approximately 132.5 cm.Conclusions: evaluation of the returned jet7 was kinked and ovalized on the distal shaft.This damage was likely the reported stretching.If the device is forcefully manipulated against resistance, damage such as this may occur.During functional testing, the jet7 was advanced through a demonstration neuron max with resistance due to the ovalization.The root cause of initial resistance during the procedure could not be determined.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.

Event Description

The patient was undergoing a thrombectomy procedure in the left m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), velocity delivery microcatheter (velocity), and non-penumbra sheath.During the procedure, the physician advanced the jet7 into the target vessel and turned on aspiration for approximately two minutes.The physician started to retract the jet7; however, resistance was encountered and the distal portion of the jet7 started to become stretched.Subsequently, the physician stopped retracting the jet7 and started retracting the sheath which in turn started to move the jet7.The physician then stopped retracting on the sheath and pulled the jet7 to remove it with the clot contained at the tip of the jet7.An angiogram was performed to reveal that the clot was removed from the artery.Post procedure, the physician mentioned a vasospasm occurred in the cervical internal carotid artery (ica) related to the sheath and, consequently, caused the jet7 to become stretched upon retraction.It was also reported that no medical intervention was performed to treat the vasospasm.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 10577806
• MDR Text Key: 208951064
• Report Number: 3005168196-2020-01549
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948020962
• UDI-Public: 00815948020962
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K190010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2022
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F95097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR