MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number 4006U0308

Device Problems Detachment Of Device Component (1104); Occlusion Within Device (1423); Inadequacy of Device Shape and/or Size (1583); Stretched (1601); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/13/2014

Event Type  Injury  

Event Description

The patient was undergoing a coil embolization procedure in the thyrocervical trunk for major aortopulmonary collateral artery using penumbra coil 400.The physician was manipulating the placement of the penumbra coil 400 and the microcatheter kicked out of the target vessel and the penumbra coil 400 appeared to be stretched.Before the physician was able to place the penumbra coil 400 into the vessel, it unintentionally detached within the microcatheter.A snare device was required to rescue the penumbra coil 400 and about two centimeters of coil remained in the left thyrocervical trunk.Since the fragment occluded the target vessel, the physician left the fragment of penumbra coil 400 in the patient.There was no report of an adverse effect on the patient.The physician's comment: the event was an anticipated error of mechanical device.I should have chosen a coil which is 2 cm shorter.

Manufacturer Narrative

Result: the coil was severely damaged.The platinum coil is completely unwound and the coil stretch resistant (sr) wire is broken.Conclusion: the compliant has been evaluated.The complaint indicates that the coil was being manipulated in and out of a 4f microcatheter several times during deployment when the microcatheter was kicked back.At this point, the physician noted that the coil appeared to be stretched.While pushing to the coil into the artery, it detached.The coil was partially retrieved with a snare device but broke during retrieval and part of the coil was left in the vessel.The returned device was severely damaged.The coil was broken in several locations including the coil sr wire.The coil may have unintentionally detached due to a break in the coil sr wire as evidenced by the physician's description that the coil "stretched." it is unlikely that the coil was stretched however, when the sr wire is broken, the coil is no longer held in tension and the coil loops may become loose.This may have appeared to be stretching.It is likely that the coil was manipulated with force in excess of the tensile strength of the coil material, causing the coil to break and detach.These devices are 100% functionally tested during processing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 4082523
• MDR Text Key: 4742218
• Report Number: 3005168196-2014-00638
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 4006U0308
• Device Lot Number: F33280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 2 YR
• Patient Weight: 10