PENUMBRA SYSTEM JET7 REPERFUSION CATHETER 5MAXJET7KIT-B 5MAXJET7KIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-28 for PENUMBRA SYSTEM JET7 REPERFUSION CATHETER 5MAXJET7KIT-B 5MAXJET7KIT manufactured by Penumbra, Inc..

Event Text Entries

[181521337] 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

[181521338] The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a velocity delivery microcatheter (velocity), penumbra system jet7 reperfusion catheter (jet7), penumbra pump, penumbra canister, non-penumbra guiding catheter, and non-penumbra stent retriever. During the procedure, the physician placed the velocity, jet7, and guiding catheter in the m1 segment and performed aspiration using the jet7. It was noted that the jet7 was connected to the pump, and the canister was placed in the pump. The physician stopped aspirating once blood was seen flowing into the canister. Subsequently, the physician flushed the jet7 with a 10cc syringe to perform an angiogram, which showed there were remaining clots in the m2 to m3 segments. The physician then re-advanced the same velocity through jet7, followed by a stent retriever. The jet7 was used aspirate the remaining clots. Next, the stent retriever was removed, but there was no blood flowing into the canister, so the physician decided to retract the jet7. While retracting the jet7 slowly, the physician continued aspiration until it was close to the acute-stage cerebral infarction. Subsequently, the jet7 was flushed with a 10cc syringe again to perform another angiogram. However, while flushing the jet7, the distal tip was kicked to the m1 segment and expanded. Contrast media was noticed in that segment. It was noted that second angiogram showed there were remaining blood clots. Upon removal of the jet7, damage on the distal tip was observed. The physician ended the procedure at this point. To treat the bleeding in the mca, the physician placed eight non-penumbra coils. On (b)(6) 2020, the patient? S condition was classified as mrs5 on the modified rankin scale (mrs). On (b)(6) 2020, the patient expired.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3005168196-2020-00273
• MDR Report Key: 9772241
• Report Source: DISTRIBUTOR,FOREIGN,HEALTH PR
• Date Received: 2020-02-28
• Date of Report: 2020-02-04
• Date of Event: 2020-01-30
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-03-19
• Date Added to Maude: 2020-02-28
• 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: 2020-02-28
• Returned To Mfg: 2020-02-14
• Model Number: 5MAXJET7KIT-B
• Catalog Number: 5MAXJET7KIT
• Lot Number: F92544
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• 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: 2020-02-28
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death; 2. Required No Informationntervention	2020-02-28