MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 8; DXE

Catalog Number SEP8

Device Problems Fracture (1260); Physical Resistance (2578); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2016

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 to treat a pulmonary embolism (pe) using an indigo system separator 8 (sep8).During the procedure, the physician placed a non-penumbra sheath in the left coronary artery and then used an indigo system aspiration catheter 8 (cat8) with the sep8 to remove thrombus.After using the sep8 with the cat8 for several passes, the physician experienced resistance and subsequently, the sep8 became stuck in the cat8 and would not move forward or backward.Therefore, the cat8 with the sep8 still inside of it was removed from the patient's body.While the devices were on the back table, the physician removed the sep8 from the cat8 and noticed that the wire in front of the sep8 bulb appeared to be fractured and unwinding.The procedure was then completed using a new sep8 and the same cat8.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Pma/510(k)# has been updated to reflect the most current 510(k) # for the device at the time of the reported complaint.Results: the indigo system separator 8 (sep8) core wire was fractured approximately 148.5 cm from the proximal end.The sep8 bulb was still intact with the coil windings of the sep8.The sep8 coil windings were separated by the investigator for further evaluation.The distal segment of the fractured core wire was intact with the distal tip of the bulb to the distal solder joint.Conclusions: evaluation of the returned device revealed that the core wire to the sep8 was fractured proximal to the bulb.This type of damage typically occurs due to improper handling during use.If the sep8 is withdrawn forcefully against resistance, damage such as this may occur.Sep8 devices are visually inspected during in-process inspection and during quality inspection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.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• Type of Device: DXE
• 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: 6056162
• MDR Text Key: 58357041
• Report Number: 3005168196-2016-01513
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016153
• UDI-Public: 00814548016153
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161523
• 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: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/14/2018
• Device Catalogue Number: SEP8
• Device Lot Number: F66926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• 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: 45 YR