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U.S. Department of Health and Human Services

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

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PENUMBRA, INC. PENUMBRA SYSTEM JET7 REPERFUSION CATHETER; NRY Back to Search Results
Model Number 5MAXJET7KIT-B
Device Problem Break (1069)
Patient Problem Fistula (1862)
Event Date 06/08/2020
Event Type  Injury  
Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
 
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), neuron max 6f 088 long sheath (neuron max), and non-penumbra microcatheter.During the procedure, the physician completed one pass in the target vessel using the jet7 and neuron max.While advancing the jet7 through the neuron max during the second pass, the physician injected contrast media, which revealed the distal tip of the jet7 was fractured.Therefore, the jet7 was removed.After removal of the jet7, it was noticed that the patient had a carotid cavernous fistula.The physician then placed a penumbra smart coil (smart coil) and non-penumbra stent to treat the carotid cavernous fistula.The carotid cavernous fistula was reported to be related to the jet7.
 
Manufacturer Narrative
Potential adverse events with the penumbra system include arteriovenous fistula, false aneurysm formation, acute occlusion, device malfunction, emboli, hematoma or hemorrhage at the site, inability to completely remove thrombus, ischemia, dissection or perforation and death are included in the labeling.Therefore, it was determined that the reported carotid cavernous fistula (ccf) was an anticipated procedural complication.Results: the jet7 was stretched from approximately 129.0 ¿ 130.0 cm from the hub.A hole was observed within the stretched region.The total length was approximately 133.0 cm.Conclusions: evaluation of the returned jet7 was unable to confirm the reported fracture, however, stretching was revealed on the distal portion of the device.Catheter stretching typically occurs due to manipulation of the device against resistance.If an angiogram is performed through a damaged catheter, additional catheter damage may result.Further evaluation revealed a small hole within the stretched region.This was likely a result of the damaged region of the device being continually manipulated and was incidental to the reported event.No other devices associated with the complaint were returned for evaluation.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.
 
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Brand Name
PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
Type of Device
NRY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key10222650
MDR Text Key197280101
Report Number3005168196-2020-00873
Device Sequence Number1
Product Code NRY
UDI-Device Identifier00815948020962
UDI-Public00815948020962
Combination Product (y/n)Y
PMA/PMN Number
K190010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/01/2005,06/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/14/2022
Device Model Number5MAXJET7KIT-B
Device Catalogue Number5MAXJET7KIT
Device Lot NumberF94269
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2020
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 06/08/2020
Initial Date FDA Received07/02/2020
Supplement Dates Manufacturer Received08/06/2020
Supplement Dates FDA Received08/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age54 YR
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