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

Catalog Number	4004C0408
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 coil (pc400 coil) pusher assembly.The pusher assembly was kinked approximately 5.0 cm from the proximal end.The introducer sheath was ovalized approximately 7.0 cm from the distal end.The embolization coil was detached from the pusher assembly within the introducer sheath.Conclusions: evaluation of the returned device revealed that the introducer sheath was ovalized.Introducer sheath ovalization typically occurs due to improper handling during use.If a rotating hemostasis valve (rhv) is over-tightened or if the introducer sheath is compressed forcefully, damage such as this may occur.The damaged introducer sheath was likely the cause of the difficulty advancing the pc400.The px slim mentioned in the complaint was not returned for evaluation.Pc400 devices are 100% functionally evaluated during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400 coils (pc400 coils).During the procedure, the physician was unable to advance a pc400 coil out of its introducer sheath and into a px slim delivery microcatheter (px slim).The pc400 coil was removed and the procedure was completed using new pc400 coils and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Date of event based on additional clarification received on 01/25/2016.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5365631
• Report Number: 3005168196-2016-00046
• Device Sequence Number: 16151276
• Product Code: HCG
• UDI-Device Identifier: 00814548010830
• UDI-Public: 00814548010830
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Report Date (Section B): 12/16/2015

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
• Operator of Device: Physician
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 4004C0408
• Device Lot Number: F63654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1