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

Model Number 3MAXC

Device Problems Stretched (1601); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 01/05/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system 3max reperfusion catheter (3maxc) was ovalized approximately 131.0 cm and stretched approximately 139.5 cm from the hub.During functional analysis, a 0.035" inch stainless steel mandrel was advanced through the hub of the 3maxc.While advancing the mandrel through the catheter; resistance was encountered as the mandrel met the ovalization in the catheter shaft and the mandrel could not be advanced any further.Conclusions: evaluation of the first returned device confirmed that the 3maxc was fractured.Visual inspection of the fracture showed evidence of material deformation and stretching.This type of damage typically occurs due to improper handling during use.If the device is forcefully retracted against resistance, damage such as this may occur.Evaluation of the second returned device revealed that the 3maxc was stretched.This type of damage typically occurs due to improper handling during removal from the packaging or preparation for use.If the device is forcefully retracted against resistance, damage such as stretching may occur.Further evaluation of the returned device revealed that the catheter shaft was ovalized.This damage was likely incidental and may have occurred while packaging the device for return to penumbra.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 number: 3005168196-2018-00276.

Event Description

The patient was undergoing a thrombectomy procedure in the right m1 segment of the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc).It was noted that the patient's anatomy was not tortuous.During the procedure, while the 3maxc was being used through a neuron max 6f 088 long sheath (neuron max), the tip of the 3maxc fractured.The physician did not mention experiencing any resistance while advancing or retracting the 3maxc through the neuron max.The broken tip of the 3maxc was aspirated back through the neuron max using the penumbra system aspiration pump max 110v (pump max) without the physician's knowledge of the fracture until the 3maxc was removed.It was reported that the remaining 3maxc tip was found in the canister.The physician then opened a new 3maxc; however, it was noticed that the 3maxc was stretched.Therefore, the 3maxc was set aside and was not inserted into the patient.The procedure was completed using the same neuron max, another catheter and a stent retriever.There was no report of an adverse effect to the patient.

Manufacturer Narrative

This report is associated with mfr report number: 3005168196-2018-00276.

• 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: 7249906
• MDR Text Key: 99796299
• Report Number: 3005168196-2018-00277
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012490
• UDI-Public: 00814548012490
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/14/2020
• Device Model Number: 3MAXC
• Device Catalogue Number: 3MAXC
• Device Lot Number: F80543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• 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: 69 YR