PENUMBRA SYSTEM JET7 REPERFUSION CATHETER 5MAXJET7-B 5MAXJET7

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-14 for PENUMBRA SYSTEM JET7 REPERFUSION CATHETER 5MAXJET7-B 5MAXJET7 manufactured by Penumbra, Inc..

Event Text Entries

[188420713] The following device code also applies to this complaint: 1069 the device has been returned and the investigation results are pending. A follow up mdr will be submitted upon completion of the device investigation.
Patient Sequence No: 1, Text Type: N, H10

[188420714] 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), velocity delivery microcatheter (velocity) and a non-penumbra guiding sheath. During the procedure, the physician dilated the radial artery, advanced the guiding sheath along with the dilator directly through the skin to the internal carotid artery (ica) and then removed the dilator. While advancing the jet7 and velocity through the check-flo hemostatic valve on the guiding sheath, the physician experienced resistance and the jet7 would no longer advance; therefore, it was removed. Upon removal of the jet7, it was noticed that the jet7 stretched and the distal end of the jet7 broke off. It was reported that the broken piece of the jet7 was stuck in the proximal end of the guiding sheath with the broken piece of the jet7 hanging out of the distal end of the guiding sheath. The physician then removed the whole system from the patient with both the guiding sheath and remaining broken piece of the jet7. The procedure was completed using a penumbra system ace 68 reperfusion catheter (ace68), same check-flo hemostatic valve and a new guiding sheath. It was reported that after the dilator was removed from the guiding sheath, the check-flo hemostatic valve contained some coil wind that the physician believed may have been stuck in the valve from the broken jet7. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3005168196-2020-00366
• MDR Report Key: 9832928
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-03-14
• Date of Report: 2020-02-19
• Date of Event: 2020-02-15
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-02-19
• Date Added to Maude: 2020-03-14
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. VERONICA FARRIS
• Manufacturer Street: ONE PENUMBRA PLACE
• Manufacturer City: ALAMEDA CA 94502
• Manufacturer Country: US
• Manufacturer Postal: 94502
• Manufacturer Phone: 5107483200
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Generic Name: NRY
• Product Code: NRY
• Date Received: 2020-03-14
• Returned To Mfg: 2020-03-05
• Model Number: 5MAXJET7-B
• Catalog Number: 5MAXJET7
• Lot Number: F93838
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PENUMBRA, INC.
• Manufacturer Address: ONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-03-14
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-14