MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 HI-FLOW KIT; NRY

Catalog Number 5MAXACE068KIT

Device Problems Entrapment of Device (1212); Stretched (1601); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2017

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 section of the internal carotid artery (ica) using a penumbra system ace 68 hi-flow kit (kit).It was noted that the patient's anatomy was tortuous.During the procedure, the physician placed a non-penumbra 9f short sheath and a non-penumbra 9f balloon catheter and then advanced the penumbra system ace 68 reperfusion catheter (ace 68) into the patient.While passing around the tortuous arch, the balloon catheter kinked and caused the ace 68 to become caught.Consequently, the ace 68 stretched and unraveled when the physician attempted to advance and retract it.Therefore, the ace 68 was removed.The physician then used a non-penumbra stent device to remove thrombus and completed the procedure.The patient was alive after the procedure; however, on the following day, the patient had another stroke in a different hemisphere and passed away.The physician does not attribute the patient's death to the penumbra device.

Manufacturer Narrative

Results: the penumbra system ace 68 reperfusion catheter (ace 68) was fractured approximately 126.0 cm from the hub and stretched from approximately 104.0 cm from the hub up to the fracture.Conclusions: evaluation of the returned device revealed that the ace 68 was stretched and fractured.These types of damages are likely a result of forceful manipulation against resistance.It is likely that when the balloon catheter kinked, it pinned the ace 68 inside the balloon catheter lumen and was likely the source of resistance felt by the physician.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.

• Brand Name: PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6358856
• MDR Text Key: 68373348
• Report Number: 3005168196-2017-00251
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016603
• UDI-Public: 00814548016603
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/15/2019
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F72874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2016
• 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: 39 YR