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

Catalog Number 4002C1660

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2014

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure using a penumbra coil 400.During the procedure, physician experienced resistance while attempting to remove the coil from the microcatheter (a non-penumbra device).The coil was removed and the procedure continued with no further issue.There was no report of an adverse effect on the patient.

Manufacturer Narrative

Conclusion: the device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Manufacturer Narrative

Result: the penumbra coil 400 was intact with the pusher assembly.The proximal end of the pusher assembly was kinked approximately 5.0 cm from the end.The pet lock was intact on the proximal end of the pusher assembly.The renegade hi-flow microcatheter (non-penumbra device) was ovalized approximately 10.5 cm from the distal tip.The outer diameter of the coil, distal detachment tip (ddt), and pusher assembly were measured and determined to be within specification.Conclusion: the complaint has been evaluated.The complaint indicates that the penumbra coil 400 was inserted through a renegade hi-flow catheter (non-penumbra device) and a strong resistance was felt.Evaluation of the returned product revealed that the distal shaft of the renegade hi-flow microcatheter was ovalized.If this ovalization was present when attempting to advance the coil, strong resistance, as described in the complaint, would be encountered.The kink in the proximal end of the pusher assembly was likely related to attempts to advance the coil against resistance.The penumbra coil 400 devices are 100% functionally tested and visually inspected for damage during process inspection.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: 4354567
• MDR Text Key: 5220899
• Report Number: 3005168196-2014-00897
• 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: 11/25/2014

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: 4002C1660
• Device Lot Number: F44806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2014
• 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 Age: 84 YR