MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Model Number 3MAXC-B

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2020-01589, 3005168196-2020-01590.

Event Description

The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using penumbra system jet 7 reperfusion catheters (jet7), a neuron max 6f 088 long sheath (neuron max), a penumbra system 3max reperfusion catheter (3maxc), non-penumbra stent retrievers and guidewires.It was reported that the patient¿s anatomy was slightly tortuous.During the procedure, the physician encountered slight resistance while advancing a jet7 with the 3macx over a wire through the neuron max and up to target vessel.The 3maxc and wire were then removed and the first past was completed using the jet7.After removal of the jet7, the physician noticed that the midshaft of the 3macx was stretched and the distal tip of the jet7 was kinked while flushing both catheters on the back table.Therefore, the 3macx and jet7 were not used for the remainder of the procedure.While advancing another jet7 and wire only through the same neuron max, the physician experienced resistance; therefore, the jet7 was removed.Upon removal, it was noticed that the midshaft of the jet7 was also kinked.The procedure was completed using non-penumbra stent retrievers, a non-penumbra catheter and the same neuron max.There was no report of an adverse effect to the patient.

Event Description

The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using penumbra system jet 7 reperfusion catheters (jet7), a neuron max 6f 088 long sheath (neuron max), a penumbra system 3max reperfusion catheter (3maxc), non-penumbra stent retrievers and guidewires.It was reported that the patient¿s anatomy was slightly tortuous.During the procedure, the physician encountered slight resistance while advancing a jet7 with the 3macx over a wire through the neuron max and up to target vessel.The 3maxc and wire were then removed and the first pass was completed using the jet7.After removal of the jet7, the physician noticed that the midshaft of the 3macx was stretched and the distal tip of the jet7 was kinked while flushing both catheters on the back table.Therefore, the 3macx and jet7 were not used for the remainder of the procedure.While advancing another jet7 and wire only through the same neuron max, the physician experienced resistance; therefore, the jet7 was removed.Upon removal, it was noticed that the midshaft of the jet7 was also kinked.The procedure was completed using non-penumbra stent retrievers, a non-penumbra catheter and the same neuron max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

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: 3005168196-2020-01591.Section b.Box 5.Describe event or problem.Results: the 3maxc was kinked approximately 80.5 cm from the hub.The 3maxc was stretched approximately 124.5 thru 125.5 cm, and 137.0 thru 165.5 cm from the hub.The 3maxc was knotted approximately 137.0 cm from the hub.Conclusions: evaluation of the first returned jet7 confirmed that the distal tip was damaged.If the catheter is forcefully mishandled during use, damage such as a kink may occur.Further evaluation of the returned jet7 revealed that the catheter was ovalized and stretched.This damage was likely incidental to the reported complaint and may have occurred post-procedure.During the functional test, resistance was encountered while advancing the jet7 through a demonstration neuron max due to the ovalization in the catheter shaft, and the jet7 could not be advanced any further.Evaluation of the second returned jet7 confirmed that the catheter was kinked.If the jet7 is forcefully advanced against resistance, damage such as a kink may occur.Further evaluation of the returned jet7 revealed that the catheter was stretched, and the distal tip was damaged.This damage was likely incidental to the reported complaint.During the functional test, resistance was encountered while attempting to advance the jet7 through a demonstration neuron max due to the stretched distal shaft, and the jet7 could not be advanced any further.Evaluation of the returned 3maxc confirmed that the catheter was stretched.If the 3maxc is forcefully retracted against resistance, damage such as stretching may occur.The kink in the jet7 may have contributed to the resistance experienced during the procedure.Penumbra catheters are visually 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.This report is associated with mfr report numbers: 3005168196-2020-01589; 3005168196-2020-01590.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report:3005168196-2020-01591.1.Section h.Box 4.Device manufacture date this report is associated with mfr report numbers: 1.3005168196-2020-01589.2.3005168196-2020-01590 h3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10591055
• MDR Text Key: 208751621
• Report Number: 3005168196-2020-01591
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019956
• UDI-Public: 00814548019956
• Combination Product (y/n): Y
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2023
• Device Model Number: 3MAXC-B
• Device Catalogue Number: 3MAXC
• Device Lot Number: F97118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR