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

Catalog Number	4006C0408
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coils 400(pc400s).During the procedure, while the physician was using a pc400 with a px slim delivery microcatheter (px slim), the pc400 unintentionally detached in the px slim.Therefore, the physician removed the px slim with the detached pc400 inside.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0 cm from the proximal end.The embolization coil was detached from the pusher assembly and had a fractured stretch resistant (sr) wire.Conclusions: evaluation of the returned devices revealed the pc400 embolization coil was detached from the pusher assembly and had a fractured sr wire.Fracture of the sr wire typically occurs due to forceful retraction of the pc400 against resistance.If the sr wire becomes fractured, it will allow the embolization coil to detach.Further evaluation revealed the pc400 pusher assembly was kinked.This damage was likely incidental and may have occurred during packaging for return.The px slim and the pc400 embolization coil were not returned for evaluation.Penumbra coils and catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6583542
• Report Number: 3005168196-2017-00784
• Device Sequence Number: 747166
• Product Code: HCG
• UDI-Device Identifier: 00814548011905
• UDI-Public: 00814548011905
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2017

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: No Information
• Device Expiration Date: 04/24/2018
• Device Catalogue Number: 4006C0408
• Device Lot Number: A34841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR