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

Catalog Number 3MAXC

Device Problems Physical Resistance (2578); Patient-Device Incompatibility (2682); Difficult to Advance (2920); Material Integrity Problem (2978); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the m1 and m2 junction of the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3max).During the procedure, the physician had difficulty advancing the 3max through the m1 and m2 junction of the mca.While navigating the 3max across the bend, the physician encountered resistance and subsequently, the 3max became damaged at the proximal hub.Therefore, the 3max was removed and the procedure was completed using a new 3max, a penumbra system 5max reperfusion catheter (5max) and the same neuron max 6f 088 long sheath (neuron max).There was no report of an adverse effect on the patient.

Manufacturer Narrative

Results: there was no visible damage to the penumbra system 3max reperfusion catheter (3max).The 3max inner diameter (id) band was skived off by the penumbra investigator to allow further evaluation.The strain relief was also unwound and broken by the penumbra investigator.No damage or abnormalities were observed under the strain relief or id band.The 3max was functionally tested and performed as intended by checking for leaks under positive and negative pressure.A 0.035¿ mandrel was advanced into the hub and out the distal tip without issue.Conclusions: evaluation of the 3max revealed no visible damage.The 3max was tested for leaks under positive and negative pressure but no leaks were observed.The strain relief and id band were removed by the penumbra investigator to further evaluate the alleged proximal hub damage but no underlying damage was revealed.The root cause of this complaint could not be determined.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

Updated event description: during the procedure, the physician had difficulty advancing the 3max and a penumbra system 5max reperfusion catheter (5max) coaxially through the m1 and m2 junction of the mca using a neuron max 6f 088 long sheath (neuron max).It was reported that the patient's anatomy was tortuous.While navigating the 3max across the bend, the physician encountered resistance and applied force to advance the 3max further.Subsequently, the 3max became damaged at the proximal hub and was removed.The procedure was then completed using a new 3max, the same 5max and the same neuron max 6f 088 long sheath (neuron max).

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5940899
• MDR Text Key: 54405525
• Report Number: 3005168196-2016-01284
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012490
• UDI-Public: 00814548012490
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K133317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 3MAXC
• Device Lot Number: F65834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR