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

Model Number 5MAXJET7KIT-B

Device Problem Material Deformation (2976)

Patient Problems Death (1802); Fistula (1862); Vascular Dissection (3160)

Event Date 04/24/2020

Event Type  Death  

Manufacturer Narrative

Potential adverse events in the labeling with the penumbra system include, but are not limited to, arteriovenous fistula, vessel spasms, thrombosis, dissection, or perforation, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, ischemia, including death.Therefore, it was determined that the reported adverse events were anticipated complications.Results: the returned jet7 was fractured approximately 129.0 cm from the hub.Conclusions: evaluation of the returned jet7 confirmed a distal fracture.This damage typically occurs due to forceful retraction against resistance.Based on the reported event, there were no retrieval attempts for the fractured tip of jet7.This indicates the device did not completely fracture until removed from the patient body.If the catheter was stretched or otherwise damaged, it may worsen to a fracture after additional manipulation.The root cause of the initial damage could not be determined.The distal tip of the non-penumbra sheath was ovalized.A demonstration jet7 was able to be advanced through the returned non-penumbra sheath without issue.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 right m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), non-penumbra stent retriever, non-penumbra microcatheter, and non-penumbra sheaths.It was reported that the patient had covid-19 and left-sided weakness with facial droop.During the procedure, the physician completed two passes in the target vessel using the jet7 with the stent retriever.The physician withdrew the stent retriever without significant resistance on both passes.The passes resulted in a thrombolysis in cerebral infarction (tici) grade 2b.A contrast run was then performed and showed a tear and a carotid-cavernous fistula (ccf) had formed.Subsequently, the physician decided to remove the jet7.Upon removal, it was noticed that the distal end of the jet7 was fractured.The procedure ended at this point.The patient had pneumonia from covid-19, left paralysis and was intubated.One day post-procedure, the patient was comatose with glasgow coma scale (gcs) 3.The patient later expired due to complications of the stroke and intracranial pressure (icp).

• Brand Name: PENUMBRA SYSTEM JET7 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: 10063449
• MDR Text Key: 191233487
• Report Number: 3005168196-2020-00657
• 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: 01/01/2005,04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/26/2022
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F94509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• 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
• Initial Date Manufacturer Received: 04/24/2020
• Initial Date FDA Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR