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

Catalog Number	4004C0615
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 26.0 and 36.0 cm from the proximal end.The embolization coil was detached from its pusher assembly and the proximal constraint sphere was inside the distal detachment tip (ddt).The stretch resistance wire (sr wire) was fractured.Conclusions: evaluation of the returned device revealed that the pc400's sr wire was fractured.This type of damage typically occurs due to forceful retraction against resistance.However, no resistance should be experience while retracting the device from its packaging hoop.Furthermore, the device cannot be loaded inside its introducer sheath, if the device is not attached to its pusher assembly.The root cause of the reported issue cannot be determined.Penumbra coils are visually 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal carotid artery (ica) using penumbra coils 400 (pc400's.During the procedure, the physician placed six pc400's in the target vessel.While removing a new pc400 from its packaging hoop, the physician noticed that the pc400 was already outside of its introducer sheath.Upon pulling back the pc400 pusher assembly, the physician noticed that the pc400 had unintentionally detached from its pusher assembly.The damaged pc400 was then set aside and the procedure was completed using a new pc400 without further issues.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6684046
• Report Number: 3005168196-2017-01066
• Device Sequence Number: 16347794
• Product Code: HCG
• UDI-Device Identifier: 00814548010885
• UDI-Public: 00814548010885
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2017

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: Physician
• Device Expiration Date: 06/25/2024
• Device Catalogue Number: 4004C0615
• Device Lot Number: F70325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2017
• Initial Report FDA Received Date: 07/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1