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

Catalog Number 4004C0412

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure using penumbra coil 400 coils.Prior to use, the physician noted that a penumbra coil 400 was broken and the coil was not used.

Manufacturer Narrative

Conclusion: this device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Manufacturer Narrative

Result: the penumbra coil 400 pusher assembly was fractured approximately 5.0 cm from the proximal end where the hypo-tube tab was located.The pusher assembly was slightly kinked approximately 20.5 cm from the proximal end.The coil was intact with the pusher assembly.The distal tip of the introducer sheath was ovalized.The distal tip of the coil was kinked.Conclusion: the complaint has been evaluated.The complaint indicates that the penumbra coil 400 was noticed by the physician as defective.Evaluation of the returned product was confirmed.The proximal end of the penumbra coil 400 pusher assembly was fractured.This type of damage typically occurs if the device was improperly handled during the removal from the packaging hoop or preparation.The distal end of the penumbra coil 400 introducer sheath was ovalized, and the distal tip of the coil was kinked; however, this damage was not mentioned in the complaint.These devices are 100% functional tested during process inspection visually inspected for damage.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: 4303029
• MDR Text Key: 5194588
• Report Number: 3005168196-2014-00850
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• 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: 12/31/2017
• Device Catalogue Number: 4004C0412
• Device Lot Number: F31972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2015
• Initial Date FDA Received: 12/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2012
• 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