MAUDE Adverse Event Report: PENUMBRA, INC. POD PACKING COIL; HCG, KRD

Catalog Number RBYPODJ60

Device Problems Detachment Of Device Component (1104); Premature Activation (1484); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the embolization coil was detached via stretch resistant (sr) wire fracture and stretched.The proximal constraint sphere was present inside the distal detachment tip (ddt) with clotted blood visible.The distal tip of the embolization coil had minimal damage distal to a large stretched section of coil.Conclusions: evaluation of the returned podj revealed a detached embolization coil due to sr component fracture.This damage was likely a result of forcefully retracting the device against resistance.Based on the embolization coil stretching pattern, it is possible the distal tip of the embolization coil become stuck on the distal tip of the catheter when cycling.Further retracting the embolization coil after it is pinned may have caused the sr component to fracture.Significant thrombus attached to the ddt likely have contributed to the resistance experienced and the eventual sr component fracture.Evaluation of the returned lantern revealed an undamaged and functional device.A demonstration coil was advanced through its length without issue.Penumbra catheters and coils 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.

Event Description

The patient was undergoing a coil embolization procedure in the lateral thoracic artery using a pod packing coil (podj) and a lantern delivery microcatheter (lantern).During the procedure, while deploying a podj in the target vessel, the physician did not like the position of the podj and pulled it back into the lantern.The physician then pushed the podj again out of the lantern, but did not like its position and decided to pull it back into the lantern.While pulling the podj back into the lantern, the physician did not feel the "one to one" motion and upon pulling the podj pusher assembly further back, the podj unintentionally detached.Therefore, the physician removed the base catheter and the lantern containing the detached coil out of the patient¿s body.The procedure was completed using other coils and another microcatheter.It should be noted that there was no noted damage to the lantern after removal.The physician just wanted to start fresh with a new microcatheter.Additionally, there was no report of an adverse effect to the patient.

• Brand Name: POD PACKING COIL
• Type of Device: HCG, KRD
• 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: 7546170
• MDR Text Key: 109360860
• Report Number: 3005168196-2018-01058
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016733
• UDI-Public: 00814548016733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: F70056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2016
• 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: 7 YR