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

Model Number 5MAXJET7KIT-B

Device Problems Break (1069); Stretched (1601); Physical Resistance/Sticking (4012)

Patient Problems Death (1802); Extravasation (1842); Device Embedded In Tissue or Plaque (3165)

Event Date 06/06/2020

Event Type  Death  

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 internal carotid artery (ica) using a penumbra system jet 7 reperfusion catheter (jet7), non-penumbra stent retriever, non-penumbra microcatheter, non-penumbra catheter, and guidewire.It was reported that the patient had a cerebral infarction.During the procedure, the physician completed the first pass in the target vessel using the jet7 with the adapt technique.It was noted that a contrast run was performed using the jet7.The contrast run showed complete recanalization of the c2 segment was not achieved, and there were no abnormalities.The physician completed the second pass using the jet7 with the stent retriever and then removed the stent retriever with some clot.After removal, the stent retriever was found damaged outside of the patient.Another contrast run was performed using the jet7.Subsequently, the physician completed the third pass using jet7 with another non-penumbra stent retriever.It was noted that while removing the stent retriever and a small amount of clot on this pass, the physician experienced resistance.The physician then injected contrast agent again though the jet7.Consequently, the distal tip of the jet7 expanded, and extravasation of the blood occurred.The physician placed six coils using another non-penumbra microcatheter to treat the extravasation.Post-procedure, the patient was transferred to the intensive care unit (icu).The patient later expired, and the patient's death was determined to be related to the jet7.

Manufacturer Narrative

Correction: please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report.1.Section b.Box 5.Describe event or problem.Please note, that the following sections were inadvertently missed on the initial mfr report.And are being updated on this follow-up # 01 mfr report.1.Section h.Box 6.Device code 3.2.Section h.Box 6.Patient code 3, h3 other text: placeholder.

Event Description

The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica).Using a penumbra system jet 7 reperfusion catheter (jet7), non-penumbra stent retriever, non-penumbra microcatheter, non-penumbra catheter, and guidewire.It was reported, that the patient had a cerebral infraction.During the procedure, the physician completed the first pass in the target vessel using the jet7 with the adapt technique.A contrast run was performed through the jet7.Complete recanalization of the c2 segment was not achieved.And there were no abnormalities noted during angiography.The physician completed a second pass using the jet7 with a non-penumbra stent retriever.Both the jet7 and stent retriever were removed together.Upon removal some clot was noted, in the stent retriever.The stent retriever was also noted, to be damaged (a wire was broken).Another contrast run was performed using the jet7.The physician completed a third pass using the jet7 with a new stent retriever.It was noted, that while removing the stent retriever through the jet7, the physician experienced resistance.A small amount of clot was removed using the stent retriever.The physician then performed, a third contrast run though the jet7.Consequently, the distal tip of the jet7 expanded and broke.And extravasation occurred.The broken distal tip remained in the patient.And the physician implanted, six coils using another non-penumbra microcatheter to treat the extravasation.The patient was transferred to intensive care unit (icu).It was reported, that the patient expired.

Manufacturer Narrative

Please note that the following section is being updated based on additional information provided by a penumbra distributor on 07/08/2020: section b.Box 5.Describe event or problem.Potential adverse events in the labeling with the penumbra system include, but are not limited to, device malfunction, 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 jet7 had kinks approximately 118.0 and 122.0 cm from the hub.The device was fractured approximately 129.0 cm from the hub.Conclusions: evaluation of the returned jet7 confirmed a distal fracture and the distal fractured segment was not returned for evaluation.Catheter fracture typically occurs due to retraction against resistance.Based on the reported event, manipulation of a revascularization device against resistance within the jet7 may have contributed to jet7 damage prior to injection.The interaction of a damage device within the jet7 lumen on the prior pass may also have contributed to jet7 damage.If an angiogram is performed through a damaged catheter, additional catheter damage will likely result.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 internal carotid artery (ica) using a penumbra system jet 7 reperfusion catheter (jet7), non-penumbra stent retriever, non-penumbra microcatheter, non-penumbra catheter, and guidewire.It was reported that the patient had a cerebral infraction.During the procedure, the physician completed the first pass in the target vessel using the jet7 with the adapt technique.A contrast run was performed through the jet7.Complete recanalization of the c2 segment was not achieved and there were no abnormalities noted during angiography.The physician completed a second pass using the jet7 with a non-penumbra stent retriever.Both the jet7 and stent retriever were removed together.Upon removal some clot was noted in the stent retriever.The stent retriever was also noted to be damaged (a wire was broken).Another contrast run was performed using the jet7.The physician completed a third pass using the jet7 with a new stent retriever.It was noted that while removing the stent retriever through the jet7, the physician experienced resistance.A small amount of clot was removed using the stent retriever.The physician then performed a third contrast run though the jet7.Consequently, the distal tip of the jet7 expanded and broke, and extravasation occurred.The broken distal tip remained in the patient, and the physician implanted six coils using another non-penumbra microcatheter to treat the extravasation.The patient was transferred to intensive care unit (icu).It was reported that the patient expired due to intracranial hemorrhage as a result of vessel damage.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10230706
• MDR Text Key: 197537681
• Report Number: 3005168196-2020-00890
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948020962
• UDI-Public: 00815948020962
• Combination Product (y/n): Y
• PMA/PMN Number: K190010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/01/2005,06/11/2020

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 Date: 09/18/2022
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F93170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• 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: 06/11/2020
• Initial Date FDA Received: 07/03/2020
• Supplement Dates Manufacturer Received: 07/08/2020; 07/08/2020; 10/04/2020
• Supplement Dates FDA Received: 08/07/2020; 08/07/2020; 12/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 47