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

Catalog Number 4006C0408

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2014

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure for a major aortopulmonary collateral artery (mapca) using penumbra coil 400 and px slim delivery microcatheter.The physician successfully deployed and detached four penumbra coils 400 through the px slim delivery microcatheter.While deploying the fifth penumbra coil 400, the penumbra coil 400 became fractured while the physician pulled back on the pusher wire.The physician attempted to advance the penumbra coil 400 into the aneurysm using a syringe, but the fragment became unraveled.The diagnostic catheter was cut open and a snare device was used to remove the penumbra coil 400.The snare attempt migrated the coil mass, however, it had no adverse effect on the patient.The patient was well.

Event Description

The patient was undergoing a coil embolization procedure for a major aortopulmonary collateral artery (mapca) using penumbra coil 400 and px slim delivery microcatheter.The physician successfully deployed and detached four penumbra coils 400 through the px slim delivery microcatheter.While deploying the fifth penumbra coil 400, the penumbra coil 400 became fractured while the physician pulled back on the pusher wire.The physician attempted to advance the penumbra coil 400 into the aneurysm using a syringe, but the fragment became unraveled.The diagnostic catheter was cut open and a snare device was used to remove the penumbra coil 400.The snare attempt migrated the coil mass, however it had no adverse effect on the patient.The patient was well.

Manufacturer Narrative

Result: (b)(4) coil was severely damaged.The coil stretch resistant (sr) wire was broken and the coil loops were pulled apart.The distal constraint sphere was tangle inside the damage coil with approximately 3.0 cm of sr wire attached.The px slim delivery microcatheter was damaged approximately 1.0 and 3.0 cm from the distal tip.The damaged section of the microcatheter was opened to expose the lumen and showed evidence of material deformation and stretching of the catheter liner material.Conclusion: a 0.025 in.Mandrel was introduced through the hub of the px slim delivery microcatheter and advanced distally with moderate force through the ovalized lumen in the distal shaft of the catheter.Both devices were damaged and therefore nonfunctional.The complaint has been evaluated.The complaint indicates that during retraction of the coil into the microcatheter, the coil unintentionally detached and appeared to have been broken.The remainder of the coil was then removed using a snare device.Prior to removal of the broken coil, the physician attempted to push the detached coil into the target location using a syringe and a guide wire.Evaluation of the returned device confirmed a break in the coil sr wire and a damaged coil.The damage to the inside of the catheter appears to have been related to attempts to push the coil or the guide wire through the lumen against resistance, causing the material lining the catheter to deform and stretch.The fracture in the coil sr wire caused the coil to detach.Stretching of the coil likely occurred due to use of the snare device to remove the coil.Fracture of the sr wire is typically related to force placed on the device in excess of the tensile strength of the sr wire material.It appears that in attempts to retract and reposition the coil, resistance was met and the coil was pulled with force.The proximal end of the coil was likely removed with the coil pusher assembly and the distal end of the coil was snared and removed from the patient.However, this cannot be confirmed as the proximal end of the coil and the pusher assembly were not returned for evaluation.The coils are 100% functionally tested during in-process inspection.In addition, the device history records for this lot were reviewed and all tested units met the specification for tensile strength.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This mdr is associated with mdr 3005168196-2014-00848.

• 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: 4303026
• MDR Text Key: 5194069
• Report Number: 3005168196-2014-00847
• 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,Followup
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 4006C0408
• Device Lot Number: F44884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 12/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2014
• 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: 5 YR